June 2015 Agreed date: Review Date: Sept 2015 June 2018 Agreement cover sheet The clinical guidelines of the Peninsula Cancer Network Colorectal Group have been agreed by: Clinical Guidelines Peninsula Cancer Network Colorectal Group Position/ Name Chair PCN Colorectal Group Steve Mitchell Position/ Name South Devon Healthcare NHS Foundation Trust Mark Cartmell Chris Gandy Melanie Feldman (Joint) Clare Ferris (Joint) Will Chambers Nick Kenefick Name/ Trust Cancer Lead Katie Cross Sarah Pascoe Giles Maskell John Rennison David Sinclair Name/ PCN Imaging Lead Gareth Porter Position/ Name Northern Devon Healthcare NHS Trust Plymouth Hospitals NHS Trust Royal Cornwall Hospitals NHS Trust Royal Cornwall Hospitals NHS Trust Royal Devon & Exeter NHS Foundation Trust South Devon Healthcare NHS Foundation Trust Organisation Northern Devon Healthcare NHS Trust Plymouth Hospitals NHS Trust Royal Cornwall Hospitals NHS Trust Royal Devon & Exeter NHS Foundation Trust South Devon Healthcare NHS Foundation Trust Organisation Plymouth Hospitals NHS Trust Position Name Position MDT Lead Clinicians/ Organisation Clinical Commissioning Groups NHS New Devon CCG Northern Locality NHS New Devon CCG Western Locality NHS Kernow CCG New NHS Devon CCG Eastern Locality NHS South Devon & Torbay CCG PCN Chemotherapy Group Chair Nigel Acheson Teenage and Young Adult Cancer Network Group Chair Date agreed Date agreed Date agreed Date agreed Date agreed Name 2 Contents Introduction .............................................................................................. 6 High Risk Groups ........................................................................................ 6 2.1 Summary of Recommendations: ...................................................................................................... 7 Referral Guidelines (Measures: 14-1C-112d) ................................................10 Access to Diagnostic Services (Measures: 14-1C-112d) ..................................10 Surgical emergencies (Measure: 14-1C-114d) ...............................................11 Clinical Investigation (Measure: 14-1C-107d) ................................................12 Imaging Indications (Measure: 14-1C-107d) .................................................13 6.1 Diagnosis..................................................................................................................................... 13 6.2 Staging ........................................................................................................................................ 13 PET-CT Indications for Colorectal and Anal Cancer Patients ............................14 7.1 Colorectal Cancer ......................................................................................................................... 14 7.2 Anal Cancer (14-1C-108d, 14-1C-111d) ...................................................15 7.3 References .................................................................................................................................. 15 Referral between MDT Teams ....................................................................16 Treatments...............................................................................................16 PCN Laparoscopic Colorectal Cancer Surgery (Measure: 14-1C-102d) ..............17 10.1 Background ............................................................................................................................... 17 10.3 South West NSSG policy .............................................................................................................. 19 10.4 References: ............................................................................................................................... 20 Anal Cancer (Measure: 14-1C-108d, 14-1C-102d) ..........................................20 11.1 Introduction .............................................................................................................................. 20 11.2 Pathology .................................................................................................................................. 21 11.3 Network Anal cancer MDT ........................................................................................................... 21 11.4 Referral Guidelines .................................................................................................................. 21 11.5 Presentation and Diagnosis ...................................................................................................... 21 11.6 Risk Factors ............................................................................................................................ 22 11.7 Staging of Primary and residual Disease ..................................................................................... 22 11.8 TNM Anal Cancer staging ......................................................................................................... 22 11.9 TNM definitions ...................................................................................................................... 22 11.10 AJCC Stage Grouping................................................................................................................ 23 11.11 References............................................................................................................................... 23 3 11.12 MDT ........................................................................................................................................ 23 11.13 Treatment .............................................................................................................................. 24 11.14 Chemo-radiotherapy ................................................................................................................. 24 11.15 Surgery .................................................................................................................................... 24 Local Excision ........................................................................................................................................... 24 Abdomino-perineal Resection ................................................................................................................. 24 Defunctioning Stoma ............................................................................................................................... 24 Groin Node Dissection ............................................................................................................................. 24 11.16 Follow-up ................................................................................................................................ 25 Follow-up I ............................................................................................................................................... 25 Follow-up II – Recommended protocol ................................................................................................... 25 11.17 Prognosis ................................................................................................................................. 25 Prognosis I ................................................................................................................................................ 25 Prognosis II ............................................................................................................................................... 25 Prognosis III .............................................................................................................................................. 26 11.18 Audit ....................................................................................................................................... 26 Early Rectal Cancer (Measures: 14-1C-110d) ................................................26 12.1 Introduction .............................................................................................................................. 26 12.2 Indication for TEM ...................................................................................................................... 26 12.3 Equipment ................................................................................................................................. 27 12.4 Patient Selection ........................................................................................................................ 27 Procedure ................................................................................................................................................. 28 Follow Up ................................................................................................................................................. 29 12.5 Results ...................................................................................................................................... 29 12.6 Summary ................................................................................................................................... 30 12.7 Referral Guidelines ..................................................................................................................... 30 Colorectal Stent Guidelines (Measure: 14-1C-103d) ......................................30 13.1 Background ............................................................................................................................... 30 13.2 Indications ................................................................................................................................. 31 13.3 Contra-Indications ...................................................................................................................... 31 13.4 Follow Up .................................................................................................................................. 31 Recurrence and Metastases .......................................................................31 Hepatobiliary Guidelines ............................................................................32 15.1 Inclusion criteria......................................................................................................................... 32 15.2 Exclusion criteria ........................................................................................................................ 32 15.3 Synchronous Metastases ............................................................................................................. 33 15.4 Staging ...................................................................................................................................... 33 15.5 Chemotherapy ........................................................................................................................... 33 15.6 Ablation therapy ........................................................................................................................ 33 15.7 After surgery.............................................................................................................................. 33 15.8 Follow-up protocol ..................................................................................................................... 34 15.9 Derriford Hospital Referral Guidelines for Colorectal Liver Metastases ............................................. 34 Palliative Care ...........................................................................................35 4 16.1 Palliative Care of Colorectal Cancer Patients .................................................................................. 36 Follow-up .................................................................................................37 5 Introduction Colorectal cancer occurs mainly in the elderly and is increasing in incidence in the UK, accounting for more than 38,000 new cases per year. Approximately half of these patients can expect to die of the disease, with one third of patients having metastatic disease evident at the time of diagnosis. Given the disease usually arises in a benign polyp and that the cure rate with current treatment modalities in early stage disease approaches 90% overall, there is considerable scope for improving the outcome for patients with colorectal cancer. Although population screening can expect to improve the overall survival by approximately 15% and ultimately reduce the incidence, current circumstances demand the prompt recognition of symptomatic disease with rapid access to effective diagnostic services and modern treatment modalities under the guidance of the multidisciplinary team. The Improving Outcomes Guidance document and Peer Review process based on the Manual for Cancer Services document aim to provide the highest possible standard of care for all patients who present with colorectal cancer. The NSSG guidelines outlined in this document are based on this principle. High Risk Groups The screening and surveillance of high-risk groups should be performed in conjunction with national guidelines (Gut 2010; 59: 666-689 doi:10.1136/gut.2009.179804). Patients who have colonic adenomas should be stratified for risk and offered colonoscopic surveillance. Subsequent surveillance should be based on previous colonoscopy findings. Patients with IBD should undergo colonoscopy with biopsies every 10cm 8 years from onset of pancolitis and 15 years from onset of left sided colitis. Colonoscopy should then be undertaken 3 yearly in second decade, 2 yearly in third decade and subsequently annually. Patients with primary sclerosing cholangitis should have annual colonoscopy and biopsy. Patients with a life-time risk of colorectal cancer of greater than 1 in 10 as a result of a family history should be offered surveillance colonoscopy. In circumstances where the familial risk is difficult to ascertain and where there is a likely genetic predisposition the advice of a clinical geneticist should be sought. 6 2.1 Summary of Recommendations: Colorectal cancer screening and surveillance in high risk groups Disease Groups Screening procedure Time of initial screen Screening procedure & interval Colorectal Cancer Consultation, LFTs and colonoscopy Colonoscopy within six months of resection only if colon evaluation pre-op incomplete Liver scan within two years post-op. Colonoscopy five yearly until 70 years Colonoscopy No surveillance or five years Cease follow up after neg ative colonoscopy Intermediate risk 3-4 adenomas, both ≥1cm Colonoscopy Three years Every three years until two consecutive negative colonoscopies, then no further surveillance High risk ≥5 adenomas or ≥3 with at least one ≥1cm Colonoscopy One year Annual colonoscopy until out of this risk group then interval colonoscopy as per intermediate risk group Large sessile adenomas removed piecemeal Colonoscopy or flexi-sig (depending on polp location Three monthly until no residual polp; consider surgery Colonoscopy 3 yearly in second decade, 2 yearly in third decade, subsequently annually Ulcerative colitis and Crohn’s colitis Colonoscopy + biopsies every 10cm Colonic adenomas Low risk 1-2 adenomas, both <1cm Pan-colitis eight years left-sided colitis 15 years from onset of symptoms Annual colonoscopy with biopsy every 10cm Annual procedures 300 000 population 175 46 IBD + primary sclerosing cholangitis +/- OLT Colonoscopy Uretero-sigmoidostomy Flex Sig At diagnosis of PSC Flex Sig annually 10 years after surgery 10 Colonoscopy 5 yearly 3 Acromegaly Family Groups Familial adenomatous Polyposis (FAP) and variants (refer to clinical geneticist) Colonoscopy At 40 years Lifetime Screening Procedure Age at initial screen (y) risk of death from CRC 1 Screening procedure and interval 1 in 2.5 Genetic testing Flex Sig + OGD Puberty Flex Sig 12 monthly. Colectomy if +ve Juvenile polyposis and Peutz-Jegher (refer to clinical geneticist) 1 in 3 Genetic testing Colonoscopy + OGD Puberty At risk HNPCC*, or more than 2 FDR (refer to clinical geneticist). Also documented MMR gene carriers 1 in 2 Colonoscopy +/OGD Aged 25 or five years before earliest CRC in family. Gastroscopy at age 50 or five yrs before earliest gastric cancer in family Two yearly colonoscopy clear the repeat at age 55 year 1 FDR <45 y with colorectal cancer 1 in 10 Colonoscopy At first consultation or at age 35-40 years whichever is the later If initial colonoscopy clear then repeat at age 55 years Flex Sig 12 monthly. Colonoscopy if +ve Annual procedures 300 000 population 6 6 23 12 8 OLT, orthoptic liver transplant, IBD, inflammatory bowel disease, FAP, familial adenomatosis polyposis; HNPCC, hereditary non-polyposis colorectal cancer; FDR, first degree relative (sibling, parent or child) with colorectal cancer; OGD, oesphageo-gastroduodenoscopy. The Amsterdam criteria for identifying HNPCC are: three or more relatives with colorectal cancer; one patient a first degree relative of another; two generations with cancer and one cancer diagnosed below the age of 50. The above family groups are for a minimum number of affected relatives – lifetime risk rises with additional affected relatives in other generations and with younger onset disease. These Guidelines assume complete colonoscopy, if incomplete then either immediate CT pneumocolon or planned repeat colonoscopy. N.B. family history may be falsely negative. People with symptoms suggestive of colorectal cancer or polyps should be appropriately investigated; they are not candidates for screening. 9 Referral Guidelines (Measures: 14-1C-112d) There should be no direct referral of newly presenting patients for large bowel investigation from primary care to individual, named colorectal surgeons or gastroenterologists. Referrals should be made in accordance with the NICE Guidelines – Referral for Suspected Cancer 2005 (www.nice.org.uk/page.aspx?o=261649 ,2 weekwait) In patients aged 40 years and older, reporting rectal bleeding with a change in bowel habit towards looser stools and\or increased frequency for 6 weeks or more, an urgent referral should be made. In patients aged 60 years and older, with rectal bleeding persisting for 6 weeks or more without a change in bowel habit and without anal symptoms, an urgent referral should be made. In patients aged 60 years and older, with a change in bowel habit to looser stools and\or more frequent stools persisting for 6 weeks or more without rectal bleeding, an urgent referral should be made. In patients presenting with a right lower abdominal mass consistent with involvement of the large bowel, an urgent referral should be made, irrespective of age. In patients presenting with a palpable rectal mass (intraluminal and not pelvic), an urgent referral should be made, irrespective of age. (A pelvic mass outside the bowel might warrant an urgent referral to a urologist or gynaecologist.) In men of any age with unexplained iron deficiency anaemia and a haemoglobin of 11g/100ml or below, an urgent referral should be made. In non-menstruating women with unexplained iron deficiency anaemia and a haemoglobin of 10g/100ml or below, an urgent referral should be made. General practitioners should advise the patient that more than one investigation may be necessary to confirm or exclude a diagnosis of colorectal cancer. Access to Diagnostic Services (Measures: 14-1C-112d) General practitioners and nurse practitioners should be aware of the various routes by which patients satisfying the high-risk criteria can gain access to diagnostic services in their locality All suspected colorectal cancers are referred to a central point in all 5 acute hospitals via one of three routes: 1. All such referrals should be made (via primary care proforma) within 24 hours usually through a dedicated fast track system. The patient will be offered a date within 2 weeks of referral (2 week wait). 2. Patients who describe symptoms which don’t entirely fulfil the criteria but are a source of concern to the GP can be referred urgently to the colorectal service out with the fast track system (Choose & Book) 3. Any patient with symptoms and signs of large bowel obstruction should be referred as an emergency to the surgical admissions unit. If possible all referrals to the colorectal service should be prioritised by the colorectal surgeon or a gastroenterologist. Surgical emergencies (Measure: 14-1C-114d) In addition to above, patients presenting as emergencies with intraluminal large bowel obstruction should be stabilised pre-operatively if necessary so that surgery can wait until it can be performed under the care of the core surgical MDT member, unless delay would be life-threatening. This applies within and outside normal working hours. To avoid unnecessary delays, patients with suspected or proven colorectal cancer should be reported to the MDT coordinator by staff in radiology, endoscopy and pathology if such local arrangements can be made. OBSTRUCTION PERFORATION or BLEEDING Resuscitate Resuscitate Contrast enema ± Colonoscopy ± CT scan Surgery Caecum in danger Caecum not in danger Surgery or Stent Refer Colorectal Surgeon MDT Surgery or Stent MDT 11 Clinical Investigation (Measure: 14-1C-107d) Patients found to have iron deficiency anaemia without an obvious cause should undergo combined gastroscopy and colonoscopy or gastroscopy with either CT colonography (CTC) or barium enema and flexible sigmoidoscopy. Patients with persistent fresh rectal bleeding alone without anal symptoms and without a rectal mass should undergo flexible sigmoidoscopy and treatment of any local causes. Patients who continue to bleed should undergo colonoscopy. Patients who describe dark or altered rectal blood +/- blood stained mucus should undergo colonoscopy. The presence of blood in the lumen of the rectum at rigid sigmoidoscopy usually indicates significant colorectal pathology. Patients with a rectal mass should undergo sigmoidoscopic biopsy sent for urgent histopathology. If possible these patients should also have a colonoscopy, CT colonography or barium enema, to check the proximal colon. CT colonography is an established technique that allows the combination of colonic evaluation with staging. It has now largely replaced the barium enema. Patients found to have an abdominal mass, thought to be colonic in origin, should undergo CT scan and possibly colonoscopy or barium enema if the diagnosis is unclear. Patients with altered bowel habit and rectal bleeding may undergo flexible sigmoidoscopy initially and in the absence of a diagnosis should undergo colonoscopy, CT colonography or barium enema . Patients with altered bowel habit and no rectal bleeding should undergo CT colonography, barium enema or colonoscopy, although patients who present with diarrhoea are best served by colonoscopy or CT colonography in the first instance. Patients who present with large bowel obstruction should have the diagnosis confirmed by CT scan, if possible, to allow staging of the abdominal disease. A water soluble contrast enema or colonoscopy may be necessary in some circumstances. Patients with major comorbidity should be offered flexible sigmoidoscopy then barium enema. If a lesion suspicious of cancer is detected perform a biopsy unless it is contraindicated. Patients who have had an incomplete colonoscopy should be offered a repeat colonoscopy, CT colonography or barium enema. All biopsies should undergo histopathological analysis as outlined by the PCN Pathology Group guidelines. The diagnosis of colorectal cancer will usually be made by endoscopic, histopathological or radiological methods, either alone or in combination. All patients who are considered for treatment should undergo the appropriate staging investigations as a matter of urgency. The imaging investigations are described in sections 6 & 7. Specific staging test should include CEA, Thoracic CT, Abdominal/ Pelvic CT scan and pelvic MRI in rectal cancer. It is advisable to image the whole colon if colonoscopy, CT colonography or barium enema can be tolerated. Further staging investigations might be necessary in light of discussion by the MDT. The diagnosis should be communicated to the patient in a comfortable, private environment preferably when accompanied by a relative or friend. A specialist nurse, who has skills in counselling, should be present at the interview. The patient should be given both verbal and written information and should be given time and support to reflect on the information. Any questions regarding the implications of the diagnosis and possible 12 treatment pathways should be answered. Advice regarding access to the service for subsequent support and information should be provided. A personal diary could provide a useful record and guide for the intended further interventions. The GP must be informed of the diagnosis by the end of the following working day. This might be by fax, telephone or email. Support and guidance are provided by the specialist nurses throughout the staging process and subsequently when the further management options are discussed. Prior discussion at the MDT meeting should be used to advise the most appropriate further treatment whether it be adjuvant treatment, surgery or palliative treatment. The patient must again be provided with all the necessary information and support to make a decision. A specialist nurse should provide advice and counselling regarding stoma care, up to and including the hospital admission. The patient can expect to start treatment within the ensuing 4 weeks. Imaging Indications (Measure: 14-1C-107d) 6.1 Diagnosis Initial diagnosis in symptomatic patients is usually via colonoscopy, CT colonography, abdominal CT, barium enema or flexible sigmoidoscopy. CT colonography has the advantage of offering full staging at the time of colonic evaluation although has the disadvantage of not being able to retrieve material for histopathological assessment. Histological confirmation of a tumour should be sought preoperatively. However if histology cannot be obtained, the findings of radiological investigations should be discussed at the MDT and a management plan determined on the merits of each individual case. If colonoscopy is incomplete then CT colonography or barium enema can be used to complete the examination of the large bowel. In the emergency setting investigation will depend on available expertise. Where feasible CT of the chest, abdomen and pelvis should be performed after resuscitation to establish a diagnosis and stage the tumour. The role for single contrast enema has lessened with modern cross-sectional imaging but may still be of value in some patients. If staging is not performed pre-operatively then formal staging CT should be completed once the patient has recovered from the surgery or stenting and prior to any proposed adjuvant therapy. Due to inflammatory changes caused by surgery post-operative staging is not recommended within 4-6 weeks of surgery. 6.2 Staging Colon and rectal cancer CT of Chest, abdomen and pelvis. Whilst Chest CT is preferred CXR can be used as an alternative. Rectal Cancer In addition to a staging CT of the chest abdomen and pelvis as above, MRI of rectum with high resolution axial T2 acquisition perpendicular to the axis of the tumour (maximal slice thickness 3mm) should be performed. 13 Tumours that are being considered for local excision may also be staged using endoluminal ultrasound, if possible. Anal cancer CT and MRI as above. PET-CT should also be considered for local and distant tumour assessment. Radiological follow up Patients who are fit and suitable for further surgical or oncological intervention and with no macroscopic evidence of residual disease will generally be considered for post-operative surveillance after finishing treatment (including adjuvant chemotherapy). This usually comprises annual CT of the chest, abdomen and pelvis for 2 years after resection of primary tumour for patients in whom further treatment with curative intent would be contemplated, continued surveillance after this point should only be considered on a specific case by case basis. The principle objective is to identify resectable liver metastases as this is the most frequent site of asymptomatic isolated recurrence in which there is a second opportunity for cure. An additional 3 month baseline CT for patients after resection of rectal tumours may be considered to reduce the difficulties in interpretation generated from any residual post-operative inflammatory mass. In addition to CT, CEA measurements are made on diagnosis, and following surgery at 3 and 6 monthly intervals until discharge at 5 years. PET scanning might be useful in some patients where there is uncertainty regarding the diagnosis of recurrent disease and prior to offering metastasis resection. When post operative follow-up investigation is considered inappropriate or declined by the patient the decision should be considered at the MDT meeting. PET-CT Indications for Colorectal and Anal Cancer Patients Positron emission tomography (PET) combined computed tomography PET-CT is a complex imaging modality, which utilises physiologically short-lived radioisotopes to distinguish biologically active from inactive tissue within pathological processes (1). PET-CT is now readily available within the South West Peninsula through a centrally provided (Plymouth) and locally reported network. 7.1 Colorectal Cancer Primary diagnosis PET-CT has no role in the primary diagnosis of colorectal cancer. It may however provide the diagnosis as an incidental finding on scans performed the other indications. Staging PET-CT has no role in the primary staging of colorectal cancer. Follow-up PET-CT has an established role in the selection of patients with proven metastatic disease detected clinically or on surveillance, who may be considered for further resections (2,3). This is to exclude other 14 undiagnosed/occult metastatic disease. This is most commonly used in the context of pulmonary and hepatic disease but has a role in patients with apparent isolated soft tissue deposits or in those patients being considered for radical pelvic clearance. PET-CT may be used to differentiate postoperative, post-radiotherapy or inflammatory changes from recurrent malignant disease (3). 7.2 Anal Cancer (14-1C-108d, 14-1C-111d) Primary diagnosis PET-CT currently has no role in the primary diagnosis of anal cancer, but as with colorectal cancer may present as an incidental finding on PET-CT performed for other reasons. Staging Although the mainstay of local staging is MRI and distant assessment with CT (4), PET-CT shows very promising results (5). This is not only for finding distant disease but also significantly upstaging local (pelvic/inguinal) nodal disease in 17% and a 19% change in radiotherapy planning (6). Follow-up PET-CT can be used to differentiate postoperative, post radiotherapy or inflammatory changes from recurrent malignant disease in planning further therapy (3,7). 7.3 References 1. PET-CT In the UK, a strategy to development and integration of the leading edge technology within routine clinical practice. Royal College of Radiologists, 2005 2. Zhang C, Chen Y, Xue H, Zheng P, Tong J, Liu J, Sun X, Huang G. Diagnostic value of FDG-PET in recurrent colorectal carcinoma: a meta-analysis. International Journal of Cancer 2009; 124(1): 167-173 3. Einat Even-Sapir, Yoav Parag, Hedva Lerman, Mordechai Gutman, Charles Levine, Micha Rabau, Arie Figer, and Ur Metser. Detection of Recurrence in Patients with Rectal Cancer: PET/CT after Abdominoperineal or Anterior Resection. Radiology September 2004 232:815-822 4. R. Glynne-Jones, J. Northover, J. Oliveira, and On behalf of the ESMO Guidelines Working Group. Anal cancer: ESMO Clinical Recommendations for diagnosis, treatment and follow-up. Ann. Onc., May 1, 2009; 20(suppl_4): iv57 - iv60. 5. Shandra Bipat, Maarten S. van Leeuwen, Emile F. I. Comans, Milan E. J. Pijl, Patrick M. M. Bossuyt, Aeilko H. Zwinderman, and Jaap Stoker. Colorectal Liver Metastases: CT, MR Imaging, and PET for Diagnosis—Metaanalysis. Radiology October 2005 237:123-131; 6. Brandon T. Nguyena, Daryl Lim Joona, Vincent Khoob, George Quonga, Michael Chaoc, Morikatsu Wadaa, Michael Lim Joona, Andrew Seea, Malcolm Feigena, Kym Rykersa, Cynleen Kaia, Eddy Zupana, Andrew Scottd Assessing the impact of FDG-PET in the management of anal cancer. Radiotherapy and Oncology. Volume 87, Issue 3, Pages 376-382 (June 2008) 7. S. Cotter, P. Grigsby, B. Siegel, F. Dehdashti, R. Malyapa, J. Fleshman, E. Birnbaum, X. Wang, E. Abbey, B. Tan. FDG-PET/CT in the evaluation of anal carcinoma. International Journal of Radiation OncologyBiologyPhysics, Volume 65, Issue 3, Pages 720-725 15 Referral between MDT Teams Not infrequently certain aspects of a specific case will need discussion at either a specialty MDT (e.g. lung or gynaecology) within the local trust or at a tertiary centre MDT (e.g. hepatobiliary). A mechanism must exist to allow referral of patients for the opinion of other MDTs and for the receipt of the decision or results. If no guidelines exist formal referral should be made to the MDT lead or the relevant MDT specialist. Treatments Pre-operative (neo-adjuvant), adjuvant radiotherapy +/- chemotherapy is indicated for some patients with rectal cancer. This treatment is undertaken in the cancer centre supervised by the clinical oncologist. The patient is initially seen by the clinical oncologist and specialist nurses to discuss the treatment schedule and likely implications. On completion of long course pre-operative chemo-radiotherapy the patient can expect surgical treatment within 6 to 8 weeks during which time the CT scan, MRI scan and EUA might be repeated to restage the disease. In patients who have had short course pre-operative radiotherapy, surgery should be scheduled for the week following completion of the radiotherapy. The adjuvant treatment schedule (including dates) should be communicated to the base hospital MDT. Prior to surgical treatment many patients benefit from attending a pre-operative assessment clinic. All patients should receive relevant thrombo-embolism prophylaxis and antibiotic prophylaxis. Bowel preparation is optional, but might vary from full bowel preparation to a simple enema in rectal and left colon resection or no preparation at all. Appropriate stoma site(s) should be marked in discussion with the patient with the aid of a qualified stomatherapist. All rectal resections and most colonic resections should be undertaken by specialist colorectal surgeons. The surgeon should aim to provide a high quality service with audited results within national standards. If possible outcome data should be submitted to the National Bowel Cancer Audit Project. Laparoscopic resection should only be performed by surgeons with appropriate expertise and the results submitted prospectively to the ACPGBI audit, following agreement with NICE. Some patients with T1 rectal cancer and some elderly or frail patients with significant co-morbidity might be considered for less invasive, local surgical excision in the form of trans-anal resection or TEMS. This might necessitate referral to a local centre with expertise in this procedure. In situations where a patient presents as an emergency with obstruction, perforation or haemorrhage every effort should be made to seek the advice of a colorectal surgeon. In obstruction, a stent might be used as either definitive treatment or as a temporary treatment to allow optimisation prior to surgical resection. All resected specimens must be submitted for histopathological analysis. The processing, analysis and reporting of pathology samples should comply with the guidelines compiled by the PCN pathology group (See Peninsula Cancer Network Colorectal Group Constitution). The use of modern techniques for colonoscopic resection of polyps has led to an increase in the number of polyps in which unsuspected malignancy is detected on histopathological examination. In these circumstances a question arises regarding the most appropriate therapeutic option (radical surgical resection versus simple 16 observation). The balance lies between the risk of residual malignancy, particularly in lymph nodes, and the risk of surgery. In the absence of any unfavourable histopathological prognostic criteria (lymphovascular invasion, poor differentiation, involved resection margins and invasion to submucosal level 3) the risk of residual lymph node metastases following polypectomy is 0.3% for pedunculated polyps and 1.5% for sessile polyps. Similarly the risk of lymph node metastases in pedunculated polyps Haggitt level 0,1,2 and 3 is <1%. On the contrary, the presence of one or more unfavourable criteria in a pedunculated polyp presents a risk of residual disease of >8% and in a sessile polyp of >14%. In Haggitt level 4 polyps and malignant sessile polyps (submucosal invasion level 3) the risk of residual disease is 12 to 25%. The risk of residual disease must be offset against the risk of surgical resection. The overall mortality from elective colorectal resection for cancer is approximately 1 to 2%, (approximately 0.2% in young fit adults and possibly >5% in the elderly and those with significant comorbidity). In general, simple observation is suitable in the absence of unfavourable criteria and patients who have a high predicted mortality rate for surgery. All patients must be discussed at the MDT meeting following surgical resection. The MDT should meet weekly if possible and the attendance of core members should be audited. Post-operative treatment is usually guided by the histopathological staging of the tumour and pre-operative staging investigations. Patients who have undergone either anterior resection or APER, who have a close or involved resection margin and who didn’t receive pre-op radiotherapy should be considered for post-op radiotherapy and chemotherapy to minimise the risk of local recurrence. All patients who have Dukes C stage disease and selected patients with Dukes B stage disease and adverse prognostic features should be considered for adjuvant chemotherapy. This usually takes the form of systemic chemotherapy which is prescribed and administered in line with current NICE guidance and when necessary following agreement by the PCN colorectal non-surgical oncology forum. All patients should receive counselling by the oncologist and specialist chemotherapy nurses who should provide information on complications and toxicities. Chemotherapy should be provided by specially trained nursing staff within a designated oncology unit under the supervision of a medical oncologist. All patients receiving chemotherapy should have access to emergency care from appropriately experienced oncology staff on a 24hr basis. Patients should be encouraged to enrol in local and nationally co-ordinated clinical trials as outlined in the PCN clinical trials portfolio. The intensity of follow-up after curative treatment remains variable and the subject of continuing investigation. The evidence based guidelines prepared on behalf of the PCN colorectal group should be used as a basis for arranging follow-up. It is appropriate in certain circumstances not to offer routine follow-up and this should be the subject of MDT discussion. PCN Laparoscopic Colorectal Cancer Surgery (Measure: 14-1C-102d) 10.1 Background Complete surgical excision of the tumour is the only potential cure and is indicated in 70% to 80% of diagnosed individuals. The remaining 20% to 30% usually have disease that has advanced to the extent that surgical resection with curative intent is unlikely to be successful. Among those who undergo surgery, the majority have 17 a good prognosis while about 30% will go on to develop advanced disease and metastases despite having apparently complete initial resection. For those with advanced disease, treatment is mainly palliative, aiming to increase the duration and quality of the person’s life while controlling symptoms. The current procedure for the surgical resection of primary colorectal tumours uses the open or laparoscopic approach. In open surgery part or all of the large intestine is removed, depending on the site and extent of the tumour. This procedure is associated with significant postoperative pain and usually involves a long hospital stay. While techniques such as epidural analgesia can effectively control postoperative pain, associated complications may require high-dependency care. Enhanced recovery protocols and new techniques for pain control have reduced the overall length of stay. Laparoscopic colorectal surgery involves inserting laparoscopic instruments through a number of ports in the abdominal wall to dissect tissues around the tumour. The tumour is usually removed through an abdominal incision, the length of which depends on the size of the tumour. Low rectal tumours, post radiation tumours (CRT), bulky T4 tumours however pose a challenge to laparoscopic surgery. CLASSIC trial showed a higher rate of CRM positives in rectal cancer surgery. NICE in its technology appraisal in 2006(1) said ‘The decision about which of the procedures (open or laparoscopic) are undertaken should be made after informed discussion between the patient and the surgeon’. In particular, they should consider: the suitability of the lesion for laparoscopic resection the risks and benefits of the two procedures the experience of the surgeon in both procedure Laparoscopic (including laparoscopic assisted/ hand port) resection is recommended as an alternative to open resection for individuals with colorectal cancer in whom both laparoscopic and open surgery are considered suitable. Laparoscopically assisted surgery refers to laparoscopic surgery in which the incision is enlarged to complete the dissection before the tumour is removed. The difference between laparoscopic and laparoscopically assisted surgery is minor, and both approaches have the advantage of requiring an abdominal incision smaller than that used in open resection. Hand-port-assisted laparoscopic surgery involves the use of a hand-port through which a gloved hand is inserted intracorporeally. NICE further concluded in 2006(1) 1. Neither the assessment report nor the consultee submissions considered made a distinction between laparoscopic and laparoscopically assisted surgery. No data were identified comparing hand-port-assisted laparoscopic surgery with open surgery. 1.1. Evidence assessed by NICE showed significantly longer operating time with laparoscopic surgery and a shorter hospital stay. Anastomotic leakage risk increased and lymph node yield decreased with use of laparoscopic surgery. 2. NICE appraisal did not show an overall survival benefit comparing open and laparoscopic resections. 3. NICE appraisal did not show any difference in tumour local recurrence in both groups. 18 4. Conversion rates: the mean overall rate was 20%. Converted patients appeared to have higher blood loss, required a longer hospital stay and have a greater risk of tumour recurrence than patients who underwent the laparoscopic or open procedure as planned. Poorer outcomes in converted patients tend to result from the individual’s condition, which influences the decision to convert, rather than as a direct result of the conversion itself. 5. Submissions from manufacturer and professional consultees contended that long-term clinical outcomes between open and laparoscopic colorectal surgery are equivalent, while short-term clinical outcomes favour the laparoscopic approach. 6. The principal arguments used by a manufacturer in its submission to NICE were as follows: (a) the conversion rate of laparoscopic to open surgery and the length of hospital stay are the two key drivers of total cost; (b) laparoscopic surgery shortens hospital stay; (c) conversion rates can be lowered to under 10% through appropriate training, mentoring and case selection, and; (d) with the control of conversion rates, the cost of laparoscopic surgery should be similar to or lower than that of open surgery. On the basis of these arguments, the manufacturer concluded that as there is no difference in long-term clinical outcomes between laparoscopic and open surgery, and short-term outcomes favour laparoscopic surgery, laparoscopic surgery should therefore be a cost-effective alternative for patients within the NHS. Laparoscopic surgery in recent studies showed reduced blood loss and pain, faster return to bowel function, earlier resumption of diet and shorter hospital days(2,3,6).It is still not very clear whether the increased cost of laparoscopic surgery would be offset by early discharge of patients(4). Counter arguments have been put forward that early discharge of patients are achieved in an enhanced recovery programme (ERAS) for open surgery. Laparoscopic surgery may be deemed to be cost effective only if there is a reduction of hospital stay by 4 days. Future studies are hoping to assess this difference for patients in an ERAS setting for open and lap surgery(5). Taking into account all these arguments and based on evidence NICE recommends laparoscopic surgery for suitable colorectal cancer patients. However, it believes, laparoscopic colorectal cancer surgery should be performed only by surgeons who have completed appropriate training in the technique and or who perform this procedure often enough to maintain competence. In 2006, UK did not have the ability or adequate number of trained consultants to offer this technique. Hence a waiver is in place until October 2010 to enable consultants to train through the national laparoscopic colorectal surgery programme or through fellowships. 10.3 South West NSSG policy Expertise of Surgeons: A list of surgeons authorised to perform laparoscopic colorectal cancer surgery to be created and held by the network. A surgeon should be either trained on the national laparoscopic colorectal surgery programme or exempt. This should be verified and signed off by the lead clinician of the MDT. The network and the local MDT should maintain this documentary evidence. It is also recommended these surgeons maintain audit data on quality of resections such as lymph node yield, CRM and margin clearance. Complications such as anastomotic leak rate, collateral injury, mortality, morbidity data and local recurrence are useful data to collect and maintain for appraisal. Minimum criteria to be offered laparoscopic colorectal cancer surgery 1. BMI less than 30 2. No previous major abdominal surgery 3. No clinical or radiological signs of obstruction 19 4. 5. 6. 7. Right sided colonic tumours/ mobile or not locally advanced Sigmoid and rectosigmoid (high) cancers T-1, T-2 and T-3 cancers( avoid T-4) Left hemi-colectomies Patients who qualify with these minimum criteria should be offered lap surgery and if accepted by the patient should be referred to surgeons with expertise either within the same MDT, or to a neighbouring MDT (named surgeon on the network list). Some centres, wherein expertise is available and surgeons have done large numbers of complex lap resections, laparoscopic or laparoscopic assisted cancer surgery can also be offered for more advanced or complex resections. It will then be the decision of the local MDT to agree on specific criteria. The MDT may choose to refer between colleagues within the same MDT if that expertise is available. In the situation wherein expertise is not available in that MDT it should be reasonable to offer open surgery for these patients. Procedures proposed are: 1. Extended right hemi-colectomies 2. Tumours requiring TME- low rectal tumours 3. Tumours requiring surgery post CRT. 4. Total Colectomy for synchronous cancers 5. Tumours in patients with previous abdominal surgery 10.4 References: 1. Laparoscopic surgery for colorectal cancer. (Review of NICE technology appraisal 17) NICE, Sept 2006. App guidance 105 2. Kamyar Kahnamoui, Margherita Cadeddu, Forough Farrokhyar, and Mehran Anvari Laparoscopic surgery for colon cancer: a systematic review. Can J Surg. 2007 February; 50(1): 48–57. 3. Wai Lun Law, Yee Man Lee, Hok Kwok Choi, Chi Leung Seto, and Judy WC Ho. Impact of Laparoscopic Resection for Colorectal Cancer on Operative Outcomes and Survival. Ann Surg. 2007 January; 245(1): 1–7. doi: 4. P J Franks, N Bosanquet, H Thorpe, J M Brown, J Copeland, A M H Smith, P Quirke, and P J Guillou. Shortterm costs of conventional vs laparoscopic assisted surgery in patients with colorectal cancer (MRC CLASICC trial) Br J Cancer. 2006 July 3; 95(1): 6 5. Perioperative strategy in colonic surgery; Laparoscopy and/or Fast track multimodal management versus standard care (LAFA trial) BMC Surg. 2006; 6: 16. Published online 2006 November 29. doi: 6. Reza MM, Blasco JA, Andradas E, Cantero R, Mayol J. Systematic review of laparoscopic versus open surgery for colorectal cancer. Br J Surg: Aug 2006; 93(8): 921-8 Anal Cancer (Measure: 14-1C-108d, 14-1C-102d) 11.1 Introduction Anal Cancer is rare. It accounts for 1-2% of gastrointestinal tumours. Annual incidence is 1 per 100,000 population. 500 cases in the UK per year. Specific expertise in management is necessary to optimise outcome. 20 11.2 Pathology Tumours involving the distal anal canal (below the dentate line) and skin of the anal margin are squamous cell cancers. Tumours involving the upper anal canal are basaloid cell tumours. Distal anal cancers drain into inguinal lymph nodes, femoral nodes and into the external iliac system Anal cancers from the upper anal canal drain into mesorectal nodes and into para-aortic nodes. The internal iliac and obturator nodes could be involved as well. 11.3 Network Anal cancer MDT All Colorectal MDTs should refer patients with anal cancer suitable for curative treatment to the Network Anal Cancer MDT. The Network Colorectal Site Specific Group has established and agreed a virtual Anal Cancer MDT which meets monthly by video conferencing. This links all five colorectal cancer local MDT’s. The Trust coordinating the Anal Cancer MDT rotates annually (January – January) and appoints a Lead Surgeon and Lead Oncologist agreed by all five local MDT’s. 11.4 Referral Guidelines Patients should be adequately investigated as per network guidelines before referral. An Anal Cancer MDT proforma is available through all five local MDT’s. Investigations: MRI, CT scan of Chest, Abdomen and Pelvis. Endoanal USS and PE-CT may also be helpful. All cases of anal cancer should be discussed at Anal cancer MDT pre-operatively, where this does not delay treatment, and recommendations made for treatment. Cases suitable for local excision as per network guidelines will be treated by nominated surgeon. Cases suitable for chemo-radiotherapy as per network guidelines will be treated with a standard chemoradiotherapy regimen agreed by the network. Cases suitable for complex resection which may include a myocutaneous flap will be treated by nominated surgeons in centres with plastic surgical support. All cases should be discussed at Anal cancer MDT post-operatively and recommendations made for further treatment, where indicated, and follow up. Follow up will be discussed with referring MDT. 11.5 Presentation and Diagnosis Patients usually present with anal mass or ulcer. They may present with anal irritation Suspicious lesions should be examined under anaesthetic and biopsied. Diagnosis should always be confirmed by histology before starting treatment. Anal skin tags excised for other reasons should always be sent for histology. Patient should be examined for clinically involved inguinal nodes. 21 11.6 11.7 Risk Factors HIV status should be assessed in homosexual males. Human Papiloma virus 16, 18 and 31 have been associated with Anal Intraepithelial Neoplasia. This may proceed to invasive cancer although the risk is not known. Immunosuppression Staging of Primary and residual Disease (See below for TMN and AJCC staging of anal cancer.) 11.8 T-Stage: MRI of pelvis should be performed to assess the T stage of the tumour. PET-CT scanning should be considered to look for nodal status and distant disease T-stage: Endoanal Ultrasound scan may improve accuracy of staging of T1 and T2 tumour. Metastases: Distant metastases should be assessed with CT scan of chest, abdomen and pelvis. 40% of patients develop metastases in chest and abdomen. Recurrent or residual disease should be restaged with MRI and CT chest, abdomen and pelvis FNA or biopsy can be used to assess inguinal nodes. A large proportion will show only reactive changes. PET-CT scan may be of value in assessing residual and metastatic disease because MRI or CT scan may not effectively differentiate between residual disease and radiation effect. TNM Anal Cancer staging The following is a staging system for anal cancer described by the American Joint Committee on Cancer (AJCC) and the International Union Against Cancer. 11.9 TNM definitions Primary Tumour (T) Tx: Primary tumour can not be assessed T0: No evidence of primary tumour Tis: Carcinoma in situ T1: 2cm or less in greatest dimension T2: More than 2 cm but no more than 5 cm in greatest dimension T3: More than 5cam in greatest dimension T4: Of any size that invades adjacent organ(s) e.g. vagina, urethra, bladder* (Note: direct invasion of the rectal wall, perirectal skin, subcutaneous tissue, or the sphincter muscle(s) is not classified as T4. Regional Lymph Nodes Nx: Regional lymph nodes can not be assessed 22 N0: No regional lymph nodes metastasis N1: Metastasis in perirectal lymph node(s) N2: Metastasis in Unilateral internal iliac and / or inguinal lymph node(s) N3: Metastasis in perirectal and inguinal lymph node(s) or bi-lateral internal iliac and/or inguinal lymph node(s) Distant Metastasis Mx: Distant metastasis can not be assessed M0: No distant metastasis M1: Distant metastasis 11.10 AJCC Stage Grouping Stage 0 Tis, N0, M0 I T1, N0, M0 II T2, N0, M0 T3, N0, M0 IIIA T1, N1, M0 T2, N1, M0 T3, N1, M0 T4, N0, M0 IIIB T4, N1, M0 Any T, N2, M0 Any T, N3, M0 IV Any T, Any N, M1 11.11 References Anal canal In: American Joint Committee on Cancer: AJCC Cancer Staging Manual 6th Ed. New York, NY: Springer, 2002, pp 125-130 11.12 MDT All patients with anal cancer should be discussed at Network designated MDT Patients with a diagnosis of anal cancer are informed of their diagnosis and counselled by a specialist cancer nurse. Their further investigations are explained to them. Patients are given written information on Anal Cancer. The patients are supported through their treatment by the specialist cancer nurse who is their Key Worker. Patients can be offered a permanent record of both their consultation and their subsequent investigations. 23 GPs are informed by letter and or a phone call when the patients are informed of their diagnosis Patients are referred to be seen by the stoma care team when necessary 11.13 Treatment The new colorectal measures state that patients should be treated in a Network designated unit(s) that has all the facilities for chemotherapy and the complex surgery of resection and formation of myocutaneous flaps and groin block dissection. In a centre managing Anal Cancer, patients should be treated by one or two named Consultant surgical core members and one or two named Consultant clinical oncology core members 11.14 Chemo-radiotherapy Current standard treatment for lesions not amenable to local excision is chemo-radiotherapy as per ACT II protocol:- 45Gy in 25 fractions plus a boost. About 90% of patient may respond fully. Few patients require surgery for skin or sphincter complications Later presentation of groin involvement can be treated by radiotherapy 11.15 Surgery Local Excision T1 tumours within 2cm of the anal margin. Abdomino-perineal Resection This is reserved for salvage after failure to respond to chemo-radiotherapy and for iatrogenic sphincter injury. A myocutaneous flap to close the perineal defect improves healing. The operation should therefore be a combined procedure with a plastic surgeon. A gynaecology oncological surgeon may be involved as well. Defunctioning Stoma This may be indicated as an adjunct in patients with advanced tumours causing loss of sphincter function or rectovaginal fistula. Groin Node Dissection 30% of patients have palpable inguinal nodes up to half of which are inflammatory. Inguinal node involvement is a prognostic factor for local recurrence and survival. FNA or node biopsy is appropriate to identify involved nodes. Radiotherapy protocols include groins in their field of treatment. 24 Later presentation of groin involvement may be treated by groin dissection or radiotherapy. The latter is associated with significant morbidity and impaired healing even with a myocutaneous flap. Block dissection after radiotherapy may be hazardous. 11.16 Follow-up Follow-up I To detect residual disease- 10% of cases after chemoradiotherapy To detect local recurrence and metastasis. 40% will develop distant metastasis. Most local recurrences diagnosed first 18-24 months. Clinical examination essential to detect local recurrence and groin nodes Examination under anaesthetic and biopsy of suspected local recurrence FNA of suspicious groin nodes All local recurrence should be staged Endoanal USS is best in demonstrating perisphinteric recurrence. MRI is best in demonstrating extrasphincteric spread CT scan of chest abdomen and pelvis detects distant metastasis PET-C. T. can increase the accuracy of local staging and detect unsuspected distant disease Follow-up II – Recommended protocol 2 monthly for 1 year 3 monthly for a second year 6 monthly subsequently CT surveillance 11.17 Prognosis Prognosis I Dependent on quality of local control Local control 5 year survival T1 90-100% 80% T2 65-75% 70% T3/4 40-55% 45-55% Local Recurrence Overall Recurrence Prognosis II Dependent on depth of invasion 25 Confined to sphincters 23% 23% Invasion through sphincters 48% 53% Prognosis III Overall 3 year survival 65% Overall 5 year survival 50% 5 year local failure rate 46% 11.18 Audit Management of anal cancer in Network designated centres should improve quality of treatment. Short term and long term results should be audited. Early Rectal Cancer (Measures: 14-1C-110d) 12.1 Introduction Transanal endoscopic microsurgery (TEM) is minimally invasive technique for the treatment of rectal tumours. It uses an endoluminal operating rectoscope with optical enhancement. It was designed by Buess and Mentges in Germany in the 1980’s and several variations have been introduced since. Its primary use is for the local excision of both benign and malignant tumours of the rectum but a number of other innovative uses have been introduced. Like all minimal invasive procedures it avoids the need for open surgery with its higher risks of morbidity and mortality and is a good alternative to open resection for rectal cancer in elderly or less fit patients with early disease. For benign tumours recurrence rates are lower than both colonoscopic endomucosal resection (EMR) and Transanal resection of tumour (TART). 12.2 Indication for TEM Buess, the originator of the TEM procedure, has outlined the specific indications he believes are best suited to TEM: Histologically confirmed adenomas in the rectum and lower sigmoid colon up to 25 cm (proximal limit) from anal verge. Well and moderately differentiated carcinoma of the preoperative stage uT1 (where ‘uT’ represents ultrasound staging of tumours) Well and moderately differentiated carcinoma of the preoperative stage uT2 in patients over 70 years or younger patients with severe risk factors Less common tumours and lesions, such as carcinoid or chronic rectal ulceration. To these indications we would add: Palliative resection of tumours > rT2 in patients with metastatic disease or not suitable for major resections. 26 We find that treating tumours between 20 cm posterior and 15cm anterior risk opening the peritoneum and this has been the only reason for conversion to anterior resection in our series. We would also add a word of caution as there is a danger that TEM could be ‘overused’ in instances where endoscopic snaring would be adequate for small polyps. 12.3 Equipment The Wolf™ TEM system consists of an operating rectoscope with a diameter of 4cm and length of 10 or 20cm. A sealed system is produced and CO2 insufflation provided by a sophisticated device to maintaining distension of the rectum and maintain intra-rectal pressure at 25cm H2O. Four ports with valves allow the passage of instruments thorough the rectoscope and maintain the sealed system. A high quality stereoscopic optical system is introduced to provide 6 x magnification. This has irrigation to clean the lens and secondary video camera for teaching purposes. The magnified 3D images allows for precise dissection of tumours. There are three working ports for various instruments including diathermy needle, suction, grasping instruments, needle holders, ultrasonic dissectors, scissors and suture nipple applicator. The rectoscope is held in position by and articulated support known as a Martin Arm. The end of the rectoscope is bevelled inferiorly to match the offset optic which looks inferiorly. The patient is therefore positioned to bring the lesion into the inferior position i.e. prone for anterior lesion and left lateral for lesions between 2 and 4 o’clock etc. A commercial system is also available from Olympus and cheap gasless system introduced by Shirouzu in Japan. 12.4 Patient Selection TEM is suitable for both benign and malignant tumours of the rectum. The suitability of patients for TEM depends on the size and site of the lesion and in the case of malignant disease the staging and differentiation. Patients co-morbidly should also be taken into account when deciding between an open procedure and TEM. TEM can be performed under general or spinal anaesthesia, however most patients not fit for general anaesthetic are not suitable for TEM as intra-operative conversion to anterior resection occurs in 4-6% of patients. TEM can be used to perform: Endomucosal resection Partial thickness resection Full thickness resection Fulguration of tumours Full thickness resection is desirable for all lesions and essential for malignant lesions if operating with a curative intent. For benign lesions the depth of excision can be modified particularly for anterior and high lesions to avoid intraperitonel incursions. TEM can therefore be used to excise benign and malignant lesions as well as palliate malignancy. Distal Extent of Lesion To perform TEM an air tight seal needs to be created around the rectoscope. It can therefore be difficult to create a seal to remove lesions within 2 cm of the dentate line. TART is a good alternative in this position. 27 Proximal Extent of Lesion Although it is possible to operate up to 25cm from the anal verge and to perform full thickness resections above the peritoneal reflection, in practice opening the peritoneum is best avoided. This risks damage to intra abdominal viscera and unless a secure suture closure performed, open conversion with anterior resection required. For practical purposes posterior lesions up to 20cm and anterior/ anterolateral lesions to 12cm may be suitable for full thickness resection. These levels can be adjusted for size, gender (lower peritoneal reflection in females) and for partial thickness excisions. Size of Lesion Although it is possible to perform full sleeve resections for benign circumferential tumours it is not usually possible to perform curative resection on malignant lesions over 1/3 circumference or 3cm. Staging of Malignant Lesions TEM doesn’t treat local lymph nodes. The risk of lymph node metastasis increase with: Depth of penetration Size of tumour (3cm) Differentiation of tumour (poorly differentiated not suitable) Lymphatic invasion and or Vascular invasion (not suitable unless considering palliative treatment). It is therefore important to get good quality and representative histology at initial biopsy. Patients should be staged with CT scan of thorax abdomen and pelvis to exclude distant metastasis. MRI to exclude mesorectal deposits or involved mesorectal/pelvic lymph nodes. C. T. colonography colonoscopy or barium enema are used to exclude synchronous lesions. Examination and possibly endoluminal ultra sound to demonstrate T stage . Number of Rectal Tumours Suitable for TEM Procedure About two to four percent of rectal cancers are suitable for potentially curative resection by TEM. Nationally 11,000 new rectal cancers present annually equating to between 220-440 cases suitable for TEM per year. Procedure The patient is prepared with full bowel preparation. Under GA the scope is inserted under direct vision up to the lesion. The lesion is positioned in the centre of the visual field by adjusting patient position. The margin of excision mapped around the tumour with the cautery. A 5 mm margin is used for small adenomas, whereas a 1 cm margin is used for larger adenomas and all cancers. Dissection is undertaken in any of the above planes depending size and type of lesion, however when removing larger adenomas and cancers excision is extended into the mesorectum. After the lesion is excised, the wound is closed transversely with a 3.0 prolene secured with silver beads at either end. It is not always possible to close the defect completely particularly if a large defect in a longitudinal axis. This does not seem to influence outcomes or result in higher rates of sepsis. Patients are usually monitored for 3 days in hospital although patients with smaller lesions discharged the following day. It is common to observe a fever for 24 hrs post operative which does not require intervention. Complications Complication rates vary between 7 to 11%. Bleeding both intraoperative and post operative up to 5 days after surgery is the most common complication. Post operatively this can be treated with TEM, packing or balloon tamponade. 28 Minor urgency incontinence occurs in up to 2% of patients due to stretching of the sphincter complex. This is more common in longer procedures and in patients with pre-existing pelvic floor weakness. This improves significantly over a few days to weeks and returns to normal by 6 months. The clinical findings are mirrored by demonstrable changes in anaorectal physiology. GTN ointment has been demonstrated to lessen sphincter injury after anterior resection. Other complications include urinary dysfunction (3%) and perianal fistulae (1.5%). In all series the incidence of complications during TEMS is lower than that of major rectal surgery. More importantly there does not seem to be any reported mortality from TEMS. Histological Analysis Specimens are pinned out on ‘cork’ boards and analysed in accordance with the guidelines set out by the Royal College of Pathologists. Data is recorded on a separate data set for local excision of rectal cancer High Risk Excisions Patients with high risk T1 tumours (R1/2 excision, poor differentiation and evidence of lymphovascular invasion or lymph node metastasis), T2 and T3 tumours should be offered radical salvage surgery unless they are unfit for this approach. Postoperative radiotherapy/chemo-radiotherapy may be an option in unfit patients. Follow Up The main aim of follow up following TEM is to: To detect local failure To detect distant metastases if malignant disease, Patients will be followed up in clinic with digital rectal examination, sigmoidoscopy or flexible sigmoidoscopy. This should be performed at 3, 6, 12 and 24 months and annual thereafter. Annual CT surveillance should be performed for two years for malignant lesions, unless there are indications to perform earlier imaging. Full colonoscopy to detect metachronous lesions should be performed on the anniversary of the procedure or at three years depending on consultant preference, the surveillance interval thereafter tailored to the individual patient. Local failure in benign disease should be treated with redo TEM, TART for very low lesions or colonoscopy and snare resection. Local failure for malignant disease will be treated with surgery in the form of anterior resection or abdominoperineal excision. This does not seem to compromise long-term outcomes for these patients. Patients should be staged and referred for neoadjuvant therapy as for all rectal cancers. 12.5 Results Malignancy Compared to low anterior resection, TEM is able to achieve comparable recurrence and survival rates for pathologic T1 (pT1) cancers, with lower morbidity and surgical mortality. TEM excision of pT1 lesions alone is considered sufficient treatment, provided the margins of excision are clear and there are no ominous pathologic features such as poor differentiation or lymphovascular invasion. Recurrence rates for favourable pT1 tumours are 4-7%, however high risk pT1 tumour demonstrate recurrence rates of 15-40%. If the tumour removed by TEM is found to be pT2 then local recurrence rates of 40% have been reported. Further therapy with either radiation and chemotherapy or radical surgery is therefore indicated. There is some evidence to show comparable survival and recurrence rates between TEM and AR (TME) for early rectal cancers using neoadjuvant therapy. This is likely to be the area of future national and international trials. 29 Benign Disease TEM has a lower recurrence rate that TART, 9 vs 26%. 12.6 Summary TEMS is a useful minimally invasive technique for treatment of benign and malignant tumours of the rectum. It can successfully treat those adenomas which are not amenable to colonoscopic excision or local excisions and can spare some patients the risks and side effects of major rectal surgery. In case of malignancy it is an acceptable treatment for favourable T1 tumours or in patients unfit for radical surgery. It does not preclude radical operations and doesn’t seem to alter long term outcome in patients coming to this surgery. It has a specific place in the management of rectal tumours and should be regarded as a therapeutic option in these patients. The role of neoadjuvant and adjuvant therapy along side TEMS needs clarifying. 12.7 Referral Guidelines Patients should have been staged with full colonic imaging and biopsies. Assessment of fixity/tethering, CT scan (thorax abdomen and pelvis) and MRI scan rectum should be performed for rectal cancers and polyps with high suspicion of malignancy (size, high grade dysplasia, endoscopic features of malignancy). Currently TEM is performed at Derriford Hospital so referral may be made there or to Mr Neil Borley in Cheltenham. Initial follow up may be performed in the TEM centre. Subsequent follow up at the parent hospital at the discretion of the referring consultant. Recommended follow up should be at 3, 6, 12 and 24 months and annually thereafter. Patients should be examined with digital rectal examination, sigmoidoscopy or flexible sigmoidoscopy. Annual CT surveillance should be performed for two years for malignant lesions, unless there are indications to perform earlier imaging. Full colonoscopy to detect metachronous lesions should be performed on the anniversary of the procedure or at three years depending on consultant preference, the surveillance interval thereafter tailored to the individual patient. Local failure in benign disease should be treated with redo TEM, TART for very low lesions or colonoscopy and snare resection. Local failure for malignant disease should be treated with surgery in the form of anterior resection or abdominoperineal excision. This does not seem to compromise long term outcomes in these patients. Patients should be staged and referred for neoadjuvant therapy as for all rectal cancers. Colorectal Stent Guidelines (Measure: 14-1C-103d) 13.1 Background The use of self expanding metallic stents for the relief of malignant colorectal obstruction is a safe and recognised procedure. Patients being offered colorectal stents should be discussed at MDT and alternative therapies explained. This is a technically demanding procedure to be undertaken only by named and trained individuals. All trusts should work towards a seven day service for stenting. 30 13.2 Indications Acute large bowel obstruction from primary bowel malignancy as a ‘bridge to surgery’ or following full staging as palliation. For imminent obstruction from primary colonic malignancy as palliation, where the disease is too advanced or the patient’s co-morbid status would make primary resection at that time carry too high a clinical risk. If clinical status improves, resection can still take place. 13.3 Contra-Indications The presence of perforation as detected on pre-procedure imaging by the plain radiographs, C. T. or contrast enema. Relative Contraindications Diffuse peritoneal malignancy. Under these circumstances stenting of the dominant stricture may not relieve the obstructive symptoms and risk benefit/symptom relief needs to be strongly considered. Cases should be reviewed on a case by case basis. Procedure The deployment of the metallic stents can be with colonoscopic/radiological techniques depending on lesion position and local expertise. 13.4 Follow Up Patients usually benefit from stool softening agents but dietary changes are seldom necessary. No other specific follow-up is required. Recurrence and Metastases Many patients (up to 30%) show evidence of metastatic disease at the time of diagnosis. Where appropriate, every effort must be made to provide the patient with a prospect of cure, although it is recognised that patients who exhibit evidence of metastatic disease after a potentially curative resection are most likely to achieve long term survival benefit from aggressive intervention. In addition to C. T. and MRI, PET-CT scanning can be used to accurately assess the burden of metastatic or recurrent disease. Patients who are considered for treatment with intention to cure should be referred to the appropriate tertiary MDT in line with any available guidelines. Combined primary liver and colonic resection can be considered in some circumstances. Pre or post-operative chemotherapy can be provided at the base hospital if necessary. Loco regional recurrence is rarely curable, but in the absence of metastases surgical resection should be considered. Patients with incurable recurrence or metastases should receive realistic information regarding therapeutic options and palliative care. They should be given the opportunity to discuss more invasive palliative treatments such as chemotherapy, radiotherapy and surgery as well as simple symptom control. Patients who have symptoms which are difficult to control should be under the care of the palliative care team. 31 Hepatobiliary Guidelines Peninsula HPB unit clinical guidelines for resection of colorectal metastases and follow-up protocol Peninsula Regional HPB Unit Derriford Hospital Plymouth PL6 8DH These guidelines are based on ‘Guidelines for resection of colorectal cancer liver metastases’ (Garden et al), published in Gut (2006;55: Suppl III, iii1-iii8) Referral guidelines have been published separately and the resection guidelines complement this document. All patients with potentially resectable colorectal metastases should be discussed at the compliant HPB MDT in the presence of HPB surgeons, oncologists and radiologists. 15.1 Inclusion criteria Solitary metastasis Multifocal unilobar metastases Bilobar metastases when approximately one-third of liver is uninvolved with tumour Extensive bilobar metastases amenable to downsizing with chemotherapy Extensive bilobar metastases amenable to downsizing with chemotherapy and staged resection/ablation (only suitable for younger and fit patients) Resectable liver lesions plus resectable lung metastases Resectable liver lesions plus isolated adrenal metastases Resectable liver lesions plus low-volume, resectable local recurrence No upper-age limit, though liver resection only offered to patients over 80 who are otherwise fit with minimal comorbidity 15.2 Exclusion criteria More than 70% of liver volume involved with tumour All three hepatic veins involved with tumour Untreatable primary disease Retro-peritoneal, mediastinal or portal malignant lymphadenopathy Widespread pulmonary metastases Peritoneal metastases Bone/CNS metastases Large-volume/unresectable loco-regional recurrence Major comorbidity 32 15.3 Synchronous Metastases Liver and colorectal resections are not normally performed synchronously. However there is increasing evidence of some benefit to this strategy, which allows completion of the surgical strategy in one in-patient stay without increased morbidity in selected patients. Synchronous resection would not be offered in the presence of aggressive primary disease (large or perforated tumour, extensive lymphadenopathy). Complex liver surgery would not be performed at the same operation as a complex colorectal resection. Synchronous resection should be considered in the presence of right-sided colonic lesions, or left-sided colo-rectal lesions with synchronous metastases in the left-lateral sector of the liver, and the strategy discussed with a core member of the HPB MDT. Most patients with synchronous metastases will receive a period of post-operative chemotherapy prior to restaging for liver resection. Patients with an aggressive primary cancer (apical node involved, vascular invasion, perforated lesions) should be considered for a PET scan in view of the high risk of extra-hepatic disease. Obvious synchronous metastases should not be biopsied. 15.4 Staging Most patients will have undergone a CT scan as part of staging for their primary disease. If a new lesion occurs in the liver following primary colorectal surgery consistent with metastasis further imaging is not usually necessary in determining treatment strategy. If resection of synchronous metastases is considered patients should usually have an MRI scan. 15.5 Chemotherapy Downsizing chemotherapy should be considered in patients with lesions which are of borderline resectability. Repeat scanning should be performed after completion of chemotherapy and a recovery period of at least one month allowed prior to liver resection. 15.6 Ablation therapy Ablation of small metastases may be appropriate treatment for patients who are unfit for surgery, after discussion with the HPB MDT. 15.7 After surgery After discharge all patients are contacted at home by the nurse specialist to monitor progress. Following surgery a letter is sent to the referring clinicians providing all operative details. All patients are followed up for one post-operative visit at Derriford Hospital 4 to 6 weeks after surgery. Histology once available is reviewed at the Regional weekly HPB MDT. Histology reports are forwarded to referring clinicians and adjuvant therapy plans discussed. 33 15.8 Follow-up protocol There are no national guidelines for follow up of these patients, and little published evidence. Some patients with recurrent disease are amenable to further resection, ablation or chemotherapy. An intensive follow up protocol of 6 monthly CT and CEA marker is advised for the first 2 years and annually thereafter for a further 3 years. This should normally be undertaken at the referring centre. Patients with resectable recurrent hepatic disease will be reviewed at the HPB MDT. Clinic visits will be normally be scheduled to follow surveillance imaging. All patients undergoing liver resection at Derriford will be offered annual follow-up. Shared follow-up between Derriford Hospital and the referring centre is preferred. 15.9 Derriford Hospital Referral Guidelines for Colorectal Liver Metastases Resection criteria: two segments plus caudate lobe uninvolved (>30% total liver volume) Synchronous metastases (liver lesions diagnosed before primary resection): CT scan sufficient Right colonic lesion plus any liver lesion or left lateral liver lesion plus any colorectal lesion Yes No Metachronous metastases (3months post-primary resection): CT scan sufficient Short-course chemotherapy* Primary resection Rescan (MRI) Consider combined resection Refer if still resectable Neoadjuvant chemotherapy trial Inoperable liver only disease Refer Downsize with Cetuximab/chemotherapy Notes In presence of aggressive primary lesion (perforated tumour/positive resection margins/EMVI/apical node positive) and synchronous metastases consider PET scan Extrahepatic disease contraindicates liver resection except adrenal/pulmonary metastases and resectable local recurrence *Chemotherapy with Oxaliplatin/Irinotecan is hepatotoxic, particularly with background of obesity, diabetes or alcohol abuse. In this situation please refer prior to chemotherapy, as ‘surgery-first’ option may be appropriate 34 Palliative Care A representative from the palliative care team should attend the MDT meetings. All patients who require palliative therapy should receive attention from the palliative care team and support for symptom control and psycho-social wellbeing throughout the course of their illness. Co-ordination of care between the community and secondary care setting is essential and the wishes of the patient must be accommodated where possible. Patients and carers should have 24 hour access to palliative care services. All patients with a colorectal cancer diagnosis should receive appropriate information and support throughout their cancer journey, from diagnosis to terminal care or cure. How that support and information is provided within each Trust and PCT will depend on local arrangements under the guidance of the local Multi-disciplinary team (MDT) for colorectal cancer. All patients should have their physical symptoms and psycho-social issues assessed at key points along their illness journey, particularly at diagnosis, completion of each treatment cycle and at follow up visits. Which professionals are responsible for carrying out this assessment and how it is carried out within each Trust and PCT will depend on local arrangements. Once the palliative care needs assessment has been carried out an appropriate management plan must be drawn up by the current caring team. This may involve referring to the specialist palliative care service locally. Specialist palliative care services have a number of common elements although their organisation may vary across the Network. All teams have access to specialist personnel, who have completed some specialist training in palliative care. The team will always have a core membership of nurses and doctors, but may also have access to other allied professions such as social work. Teams will be able to provide support in all care settings, although how this is achieved will vary in each locality. All teams will have access to specialist palliative care beds (usually in a hospice setting) and may have access to specialist day care services. All specialist palliative care services will accept referrals from any professional involved in heath or social care and some will accept self referrals. In all cases the patient must have a progressive, potentially life threatening illness and have some type of complex need which the current caring team do not have the resources to meet. Complex needs are not tightly defined as they will vary depending on the resources available to the current caring team. The specialist palliative care team will only take over the care of a patient when they are admitted to a specialist palliative care bed, otherwise the team will work with the current care providers to address issues raised. In some cases this may be through telephone advice to the professionals involved, but in others will involve face to face assessment of the patient and ongoing support. Key messages: The provision of good general palliative care, in terms of information and general support is the responsibility of all staff Not everyone with a cancer diagnosis needs a specialist in palliative care Not everyone with a cancer diagnosis wants to see a specialist in palliative care If you are not sure who should be referred or when, discuss your concerns with your local specialist palliative care provider 35 16.1 Palliative Care of Colorectal Cancer Patients General Comments Prognosis is closely linked to histological staging. Chemotherapy may be helpful in prolonging disease free survival. Specific pain complexes Liver metastases often occur and may cause pain. This usually responds well to non-steroidal antiinflammatory drugs (NSAIDs) or steroids. Liver metastases may also lead to hepatomegaly that may cause squashed stomach syndrome with delayed gastric emptying and a feeling of fullness. This may respond to a prokinetic agent such as metoclopramide. Perineal and pelvic pain may be caused by advancing disease or by surgical intervention. There is nearly always a neuropathic element to the pain that will only be partially opioid sensitive. Adjuvant analgesics such as antidepressant and/or anticonvulsant medication may be needed as well as more specialist interventions such as nerve blocks. Tenesmus is a unique type of neuropathic pain. It requires specialist assessment, but may respond to drugs that have an effect on smooth muscle including nifedipine. Bone metastases. These are becoming increasingly common, perhaps due to the role of adjuvant chemotherapy on the natural disease course. Management of subsequent pain may be difficult and specialist advice should be sought. Other complications Bowel obstruction unless it can be palliated surgically should be managed medically using a syringe driver containing a mixture of analgesics, anti-emetics and anti-spasmodics. Naso-gastric tubes are rarely needed, and hydration can often be maintained orally if the nausea and vomiting are adequately controlled. Fistulae between the bowel and the skin or bladder may occur. These can be very difficult to manage and require a multidisciplinary approach with specialist input. Anorexia and altered taste are very common with advanced disease and difficult to manage, particularly for the family. Small, frequent and appetising meals may help as may supplement drinks. Low dose steroids may temporarily boost the appetite. Rectal discharge and bleeding are unpleasant and difficult symptoms to manage. They may respond to palliative radiotherapy. Seek specialist advice. Hypoproteinaemia is common due to poor oral intake and poor absorption from the bowel and may lead to lower limb oedema. This may be complicated by pelvic disease causing to lower limb lymphoedema. Early assessment by the specialist lymphoedema service is essential to maintain patient’s comfort and prevent complications. Anaemia may occur due to chronic bleeding from the tumour. This may warrant regular blood transfusion to maintain quality of life and reasonable symptom control. Discussion is needed about the appropriateness of repeating transfusion if the anaemia is persistent. Cerebral metastases are less common, but more likely in patients with a rectal carcinoma. Decisions about investigation and management may be complex and need to be made on an individual basis. There is a risk of epileptic fits and prophylactic anti-convulsant medication may be appropriate. 36 Follow-up Suitability for follow-up confirmed at Multi-disciplinary Team discussion. Some patients will either be simply followed up by Colorectal Specialist Nurse without investigation or discharged from follow up. ASA grade noted. Developing co-morbidity during follow up period will influence appropriateness of further investigations. 37 38