ESGE Guideline on Video Capsule Endoscopy JF REY, G GAY, A KRUSE, R LAMBERT and the ESGE Guidelines Committee Video capsule endoscopy (VCE) represents a significant advance in the investigation of intestinal diseases1. Performance of the procedure and indications are reviewed in order to establish a guideline for its use in accordance with current knowledge from clinical practice and literature. Video Capsule Endoscopy is a new technique using a disposable videocapsule that is swallowed by the patient. This allows for the visualization of the segment of the small bowel, not within the reach of standard upper and lower endoscopy. The main current indication is an obscure source of gastrointestinal bleeding. VCE may be particularly helpful in discovering the cause of bleeding when standard upper endoscopy and colonoscopy are negative. I. DESCRIPTION OF THE PROCEDURE The VCE procedure can be conducted completely in out-patients. The patient is instructed to fast 12 hours before the procedure. The patient wears a shoulder-supported belt pack holding a power supply containing 5 (D-cell sized) nickel-metal 1.2 V batteries, and a small 305 gigabyte hard drive for archiving received images. Before ingestion of the capsule, an antenna array is taped to the patient’s anterior abdominal wall in a designated pattern and connected to the hard drive. Correlation of the luminal findings with the general capsule location in the abdomen is attempted by means of triangulation of the signal received by the 3 closest aerial ports. Patients are allowed to drink clear liquids 1 hour after ingestion of the capsule and to eat a light meal 4 hours after ingestion. During the recording time, patients are instructed to record abdominal symptoms in a diary and are requested to intermittently check the blinking light on the belt pack for confirmation of signal reception. After 8 hours the sensor array and the data recorder are removed and the recorded digital information is downloaded to the computer workstation. The capsule is excreted naturally, usually within 24 to 48 hours. 1 In this guideline all technical features refer to the M2A Given Imaging Video Capsule. Page 1 of 5 Data is downloaded from the belt pack recorder to a customized PC workstation. This process takes 2 to 3 hours. Proprietary software is then used to review the images in an adjustable rapid scan mode that can display between 1 and 25 frames per second. For subsequent access, thumbnail video clips of segments incorporating 50 images before and after an identified finding can be annotated and saved. Reading time and interpretation of images requires an average of 40 to 60 minutes. A few issues remain unresolved regarding procedure and patient preparation. Experts' consensus tends to recommend a systematic preparation of the patient for bowel cleansing with 2 liters of polyethylene glycol, administered either in the evening of the day before the recording or on the same day, at least 2-3 hours before ingestion of the capsule. This preparation has the advantage of cleansing the terminal ileum and thus allows a better examination II. READING OF THE RECORDED PICTURE 1. Localization In addition to the capsule itself, a localization feature has been developed and displayed in the workstation software. It enables the estimation of the location of pathologies within an average range of 3.77 cm. Capsule location in the abdomen is attempted by means of triangulation of the 3 closest aerial ports, selected on the strength of the signal received from the capsule by the 8 sensors on the abdominal wall. The location is then calculated from the position of these sensors and projected as a 2-D image. However, in clinical practice, the identification of the location of the lesion is frequently felt to be too imprecise and is mainly based on the image of the distinct mucosal pattern in the jejunum and the ileum. 2. Suspected Bleeding Indication An indicator (Suspected Blood Indicator), which automatically marks images that correlate with suspected blood or red areas in the small intestine, has been developed and is helpful for the identification of bleeding sites during the reading process. The clinical relevance of this software feature is still to be evaluated. Page 2 of 5 3. Multiviewing The multi-viewing of video stream was recently added to the software for the reading of the VCE recordings. It is characterized by the display of two contiguous images of the recording on separate windows. III. INDICATIONS 1. Obscure Digestive Bleeding Diagnosis of obscure bleeding is currently the most frequently used indication for VCE application. Obscure bleeding is defined as either recurrent episodes of digestive bleeding, i.e. melena or hematochezia, or a positive fecal occult blood test or a chronic iron-deficiency anaemia after a negative finding in gastroscopy and colonoscopy. Patients with obscure GI bleeding should undergo one more upper GI endoscopy performed by an expert using a lateral viewing endoscope to exclude missed lesions within the reach of the endoscope (like postpyloric or postbulbar ulcers) as well as lesions in the third and fourth part of the duodenum. The diagnostic yield for VCE varied from 55 % to 81 %. In comparative studies, VCE appeared constantly superior to other investigations in the diagnosis of the source of bleeding. 2. Other Indications Currently Accepted a. Investigation of Crohn's Disease There is a growing acceptance of the use of VCE in Crohn’s Disease. Several comparative studies have evaluated the diagnostic yield and compared it to various radiological modalities. VCE detects intestinal lesions in a large subset of patients with known Crohn's disease and also detects intestinal lesions frequently in patients with a clinical and/or biological suspicion of Crohn. Diagnostic yield varies from 43 to 71 %. VCE thus frequently extends the involvement of the gut or detects lesions compatible with the diagnosis. However these results must be carefully analyzed for several reasons: (i) comparison has been made in most studies versus small bowel follow-through, which is not the most sensitive radiological examination; (ii) patients included in the studies represent different clinical situations, for which the outcome of intestinal investigations must be assessed in different ways (iii) most studies included a limited number of patients; (iv) it is not clear from these reports whether the Page 3 of 5 diagnosis of Crohn's disease was confirmed afterwards with biopsies. Clinical trials are currently undertaken to validate these indications. On the other hand, it could be worth using the Patency Capsule® in those patients with a higher risk of intestinal stenosis. b. Evaluation of the Side Effects of Non Steroidal Inflammatory Drugs (NSAIDs) Several studies have shown that intestinal lesions are frequent in patients treated with NSAIDs. The clinical picture may include overt or occult bleeding, abdominal pain or intestinal obstruction, in case of a stenosis. Lesions most frequently found are ulcers and erosions. c. Hereditary Polyposis Syndromes One may consider the use of VCE for the surveillance of hereditary polyposis syndromes (Familial adematous polyposis (FAF needs biopsy in order to assess the risk), Familial juvenile polyposis) 3. Prospective Indications a. Complicated Coeliac Disease VCE could be of interest in exploring coeliac patients presenting atypical symptoms or chronic iron-deficiency anaemia. In patients with a known diagnosis of coeliac disease, VCE is indicated in the case of a symptomatic relapse despite compliance with a gluten-free diet. In this situation, VCE reveals a pattern of ulcerative jejunitis or T lymphoma. b. The Capsule in Children A few reports have so far evaluated the feasibility and clinical usefulness of VCE in children. VCE is safe in children of approximately 9 years of age and above. In younger patients, some attempts have been performed with endoscopic release of the capsule in the stomach. VI. TOLERANCE AND SAFETY 1. Overall Tolerance and Contraindications Overall tolerance of VCE by patients has been impressively good in all studies. The capsule should be used with caution in patients with known or suspected gastrointestinal obstruction, Page 4 of 5 fistulae and swallowing disorders. Recent data suggest that the radio frequency signal of VCE does not interfere with cardiac pacemakers. Safety in pregnancy has not been established yet. 2. Blockade of Capsule Progression The presence of a tight stenosis or of a large polyp may cause the blockade of the capsule progression and may require treatment. In all situations considered at risk, such as polyposis syndromes, NSAIDS complications, Crohn’s disease, it should be considered mandatory to complete a patient questionnaire about intestinal symptoms that could raise a contraindication. Studies are conducted to validate the clinical usefulness of a sham-test with Patency System® (dissolvable capsule) prior to the real test. 5. CONCLUSION VCE is an exciting new possibility for exploring the digestive lumen. However, it should be clear that at the present time VCE is an agent to upper and lower GI endoscopy. It is generally preferred to time consuming diagnosis enteroscopy and could lead to further developments in therapeutic enteroscopy. It is now the preferred test for mucosal imaging of the entire small intestine. The absence of reimbursement in major European countries is still a major drawback. Page 5 of 5