A Systematic Review of the Validity of Endoscopic Ultrasound for Esophageal Carcinoma Staging 3rd presentation Class 3: Ana Maria Reis, Ana Margarida Rodrigues, Ana Raquel Marçôa, Ana Raquel Freitas, Ana Raquel Marques, Ana Raquel Barreira, Ana Coelho, Ana Rita Linhas, Ana Rita Maia, Ana Rita Dias, Luís Gomes, Miguel Castro. Project Manager: Mário Dinis Ribeiro Introdução à Medicina Faculty of Medicine – University of Porto 1 EUS for Esophageal Carcinoma Staging Introdução à Medicina Sistematic Review to evaluate validity of a diagnosis test: EUS Sensitivity: probability of, being ill, have a positive test Especificity: probability of, not being ill, have a negative test Faculty of Medicine – University of Porto 2 EUS for Esophageal Carcinoma Staging Introdução à Medicina INTRODUCTION (I) Esophageal cancer is the eighth most common cancer in the world [1]. Patients with esophageal cancer have less than 10% 5-year survival despite advances in multimodality therapy [1]. [1] Allan Pickens, MDª, Mark B., Orringer, MDª. Geographical distribution and racial disparity in esophageal cancer.2003, 76:S1367-S1369. Faculty of Medicine – University of Porto 3 EUS for Esophageal Carcinoma Staging Introdução à Medicina INTRODUCTION (II): Curative attempts: Surgery Chemotherapy Radiation [2]. [2]Kiran S.Parmar,MD,Joseph B. Zwischenberger,MD,Angela L. Reeves,CGRN and Irving Wacman,MD.Clinical Impact of Endoscopic Ultrasound-Guided Fine Needle Aspiration of Celiac Axis Lymph Nodes (M1a Disease) in Esophageal Cancer.2002,73:916-21. Faculty of Medicine – University of Porto 4 EUS for Esophageal Carcinoma Staging Introdução à Medicina INTRODUCTION (III): The esophageal cancer is usually treated according to tumour stage as defined in the TNM system developed by the American Joint Commission on Cancer [3]. TNM classification T0 T1 T2 T3 T4 N0 N1 a See Fleming et al Definition No evidence of primary tumor Tumor invades submucosa or lamina propria Tumor invades muscularis propria Tumor invades adventicia Tumor invades adjacent structures No regional lymph nodes involved Regional lymph nodes present [3]J. Vickers and D. Alderson. Oesophageal cancer staging using endoscopic ultrasonography.1998,85,994-998. ª Fleming I, Cooper JS, Hensen DE, et al., editors. AJCC cancer staging manual (esophagus), 5th ed. Philadelphia: Lippincott-Raven, 1997:65-69. Faculty of Medicine – University of Porto 5 EUS for Esophageal Carcinoma Staging Introdução à Medicina INTRODUCTION (IV): Staging: Computerized tomography scan (CT-scan) Magnetic resonance (MRI) Endoscopic ultrassound (EUS) [4]. [4]Kiran S. Parmar,MD,Joseph B.Zwischenberger,MD,Angela L. Reeves,CGRN and Irving Wacman,MD 2002,73:916-21. Faculty of Medicine – University of Porto 6 EUS for Esophageal Carcinoma Staging Introdução à Medicina INTRODUCTION (V): Endoscopic ultrasound (EUS) has a central role in the initial staging of esophageal cancer, most notably because of its accuracy in determining depth of tumour invasion and regional lymph node metastases [4]. Faculty of Medicine – University of Porto http://www.b5orland-groover.com/articles/eus.htm 7 EUS for Esophageal Carcinoma Staging Introdução à Medicina AIM: The aim of this study is to evaluate the consistency and validity of EUS namely in determining T3 + T4 or N+ for esphageal cancer. Faculty of Medicine – University of Porto 8 EUS for Esophageal Carcinoma Staging Introdução à Medicina METHODS: Metanalysis Data Source Quality Criteria Data to be extracted Statistical analysis Faculty of Medicine – University of Porto 9 EUS for Esophageal Carcinoma Staging Introdução à Medicina METHODS (I): Data Source: Articles were searched using MEDLINE data base using the following clinical QUERY: (((((((((((("sensitivity and specificity"[All Fields]) OR "sensitivity and specificity/standards"[All Fields]) OR "specificity"[All Fields]) OR "screening"[All Fields]) OR "false positive"[All Fields]) OR "false negative"[All Fields]) OR "accuracy"[All Fields]) OR (((("predictive value"[All Fields] OR "predictive value of tests"[All Fields]) OR "predictive value of tests/standards"[All Fields]) OR "predictive values"[All Fields]) OR "predictive values of tests"[All Fields])) OR (("reference value"[All Fields] OR “reference values"[All Fields]) OR "reference values/standards"[All Fields])) OR ((((((((((("roc"[All Fields] OR "roc analyses"[All Fields]) OR "roc analysis"[All Fields]) OR "roc and"[All Fields]) OR "roc area"[All Fields]) OR "roc auc"[All Fields]) OR "roc characteristics"[All Fields]) OR "roc curve"[All Fields]) OR "roc curve method"[All Fields]) OR "roc curves"[All Fields]) OR "roc estimated"[All Fields]) OR "roc evaluation"[All Fields])) OR "likelihood ratio"[All Fields]) AND notpubref [sb])). AND (("Endosonography"[MeSH] AND "Esophageal Neoplasms"[MeSH] staging) NOT cardia) LIMITS: title/abstract. Walter L. Devillé at al.”Conducting systematic reviews of diagnostic studies: didactic guidelines”. BMC Medical Research Methodology 2002, 2:9 Faculty of Medicine – University of Porto 10 EUS for Esophageal Carcinoma Staging Introdução à Medicina METHODS (II): Data Source: Articles were also searched using Scopus data base using the following clinical QUERY: “Endoscopic ultrasound” OR “endosonography” AND “Esophageal carcinoma” OR “esophageal neoplasm” AND NOT “Cardia” Faculty of Medicine – University of Porto 11 EUS for Esophageal Carcinoma Staging Introdução à Medicina METHODS (III): Data Source 79 articles PUBMED: 106 articles Faculty of Medicine – University of Porto 27 75 articles SCOPUS: 102 articles 12 EUS for Esophageal Carcinoma Staging Introdução à Medicina METHODS (IV): Inclusion Criteria: Staging of esophageal carcinoma Endoscopic ultrasound or ecoendoscopy Surgery (gold standard) Exclusion Criteria: Cardia Articles that are not in Portuguese, English, French and Spanish Case reports Other classification of staging other than TNM classification of malignant tumours Extracted data unable to fill a 2 by 2 table of results (*) (*) only aplied to entire article Faculty of Medicine – University of Porto 13 EUS for Esophageal Carcinoma Staging Introdução à Medicina Start Pubmed and Scopus Search FLOWCHART 181 Articles found : 181 Revision of titles and abstracts Excluded by 2 reviewers 127 excluded articles: - cardia (n=13); - articles not English, Portuguese, French or Spanish (n=9); - case reports (n= 25); - Other classification of staging other than TNM classification of malignant tumours (n= 46) - extracted data unable to fill a 2 by 2 table of results (n=37) - Articles not found (n=10) Yes No Included by 2 reviewers 127 excluded articles: - cardia (n=13); - articles not English, Portuguese, French or Spanish (n=9); - case reports (n= 25); - Other classification of staging other than TNM classification of malignant tumours (n= 46) - extracted data unable to fill a 2 by 2 table of results (n=37) - Articles not found (n=10) NO Included by a 3rd reviewer Yes 54 included article Yes Read complete article Quality 10 10 articles included Introduce dates in SPSS End Faculty of Medicine – University of Porto No Introduce dates in Metadisc 14 EUS for Esophageal Carcinoma Staging Introdução à Medicina METHODS (V): Quality Criteria After being selected, the articles had to be evaluated relatively to their methodological quality. The assessment of the methodological quality of each study was performed using a scale ranged from 0 to 24 points according to the following points: Introduction (1) Results: participants (3); test results (2); estimates (2). Faculty of Medicine – University of Porto Methods: participants (4);data collection (4); test methods (5); statistical methods (2). 15 EUS for Esophageal Carcinoma Staging Introdução à Medicina METHODS (VI): Section Introduction Methods Participants Data collection Test methods Statistical methods Results Participants Test results Estimates State the research questions or study aims Inclusion criteria for the study population Exclusion criteria for the study population Setting where the data were collected Location where the data were collected Participants where selected based on diagnosis and not over another staging procedure Clinical diagnosis and inclusion was made before knowledge of reference test Consecutive sample Before or after the index tests and reference test (prospective or retrospective studies) Reference standard (reference of TN of surgery) and its rationale Technical specifications of material (type of instrument and/or frequency of the endoscope) How measurement were taken When were measurement taken Definition of categories (T and N) cut-off points for reference standard or clinical outcome (death for instance) Readers of reference and index tests where or where not blind to the results of other tests Methods for calculating or comparing measurements of diagnostic accuracy, and the statistical methods used to quantify uncertainty Methods for calculating test reproducibility, if done Demographic information (age, sex) Clinical characteristics of the study population (spectrum of disease) and severity Number of participants satisfying the criteria for inclusion that did not undergo the index tests and/or the reference standard; describe why participants failed to receive either tests A cross tabulation of the results of the index tests by the results of the reference standard Time between the index test and the reference test, and any treatment administrated between Estimates of diagnostic accuracy and measurements of statistical uncertainty Estimates of test reproducibility, if done Patrick M. Bossuyt et al. “Towards Complete and Accurate Reporting of Studies of Diagnostic Accuracy: The STARD Initiative”. Ann Intern Med. 2003; 138:40-44 Faculty of Medicine – University of Porto 16 EUS for Esophageal Carcinoma Staging Introdução à Medicina Endoscopic ultrasound METHODS (VII): T1 T2 T3 T4 N0 N1 N2 T1 Extraction Data: T2 Data were extracted according to TNM classification for EUS and surgery. Endoscope frequency, type of instrument, number and type of observers, number of patients Faculty of Medicine – University of Porto T3 Surge ry T4 N0 N1 N2 17 EUS for Esophageal Carcinoma Staging Introdução à Medicina METHODS (VIII): Data were introduced in SPSS data base. Data were introduced in Metadisc. Statistical analysis: Data analysed in Metadisc. Chi-square test was used to statistically test the presence of heterogeneity. Forrest Plots with results grouped by dates, frequency and number of patients. Faculty of Medicine – University of Porto 18 EUS for Esophageal Carcinoma Staging Introdução à Medicina RESULTS (I): Extraction Data Articles T. Lok Tio et al. 1989 M. J. Hodijek et al. 1993 S. Natsugoe et al. 1996 Ernesto Laterza et al. 1999 Gregory Zuccaro et al. 1999 Jan Heidemann et al. 2000 L. B. Nesje et al. 2000 Enrique VazquezSequeiros et al. 2001 Sónia J. Wakelin et al. 2001 Ishaan Kalha et al. 2004 Endoscope Frequency 7.5 MHz 12 MHz 20 MHz Type of instrument Olympus Number of observers Number of patients 3 171 Yes Yes _____ Yes _____ _____ Olympus _____ 32 Yes _____ _____ Toshiba _____ 37 _____ _____ EUS and EUS-FNA _____ 126 Yes Yes _____ Olympus 1 97 Yes Yes _____ GFUM20 radial SCANNING device 4 61 Yes Yes Yes Toshiba 1 or 2 107 Yes Yes _____ _____ _____ 37 Yes Yes _____ EUM 20 oblique echoendoscope 2 29 Yes Yes _____ Olympus 1 135 Yes Faculty of Medicine – University of Porto 19 EUS for Esophageal Carcinoma Staging Introdução à Medicina RESULTS (II) Methodological Quality Evaluation T. Lok Tio et al. 1989 M. J. Hodijek et al. 1993 S. Natsugoe et al. 1996 Ernesto Laterza et al. 1999 Gregory Zuccaro et al. 1999 Jan Heidemann et al. 2000 L. B. Nesje et al. 2000 Enrique Vazquez-Sequeiros et al. 2001 Sónia J. Wakelin et al. 2001 Ishaan Kalha et al. 2004 0 5 10 Introduction 15 Methods 20 25 Results Graphic 1: Methodological Evaluation Median: 16,5 Minimum: 11 Faculty of Medicine – University of Porto Maximum: 20 20 EUS for Esophageal Carcinoma Staging Introdução à Medicina RESULTS (III): Staging – T parameter Sensitivity and specificity Graphic 2: T sensitivity Graphic 3: T specificity Faculty of Medicine – University of Porto 21 EUS for Esophageal Carcinoma Staging Introdução à Medicina RESULTS (IV): Staging - N parameter Sensitivity and specificity Graphic 4: N sensitivity Graphic 5: N specificity Faculty of Medicine – University of Porto 22 EUS for Esophageal Carcinoma Staging Introdução à Medicina DISCUSSION: All grafics, except grafic 5 for N specificity, show heterogeneity (p < 0,05). Results were grouped by frequency, dates, number of patients. Subgroup analysis didn’t explain heterogeneity. Faculty of Medicine – University of Porto 23 EUS for Esophageal Carcinoma Staging Introdução à Medicina DISCUSSION: In T specificity the article with a more discrepant result is L. B. Nesje et all. 2000. Its results can be explained because it is the only one that uses 20 MHz has frequency. The reason for the discrepancy visualized in the graphics related to N sensitivity may be related to the changes that chemotherapy and radiation (treatments used) have on the intrawall layers of the esophagus. Faculty of Medicine – University of Porto 24 EUS for Esophageal Carcinoma Staging Introdução à Medicina DISCUSSION: Although heterogeneous, EUS appears to be more specific than sensitive. Faculty of Medicine – University of Porto 25 EUS for Esophageal Carcinoma Staging Introdução à Medicina LIMITS: Not all the articles had classifications for both T’s and N’s. Secondary data. Articles included that are not in the Internet, FMUP Library or IPO Library. Faculty of Medicine – University of Porto 26 EUS for Esophageal Carcinoma Staging Introdução à Medicina CONCLUSION: As the results are heterogeneous, it hasn’t been possible to do a metanalysis. EUS should continue to be used as a diagnostic test in staging esophageal carcinoma. Faculty of Medicine – University of Porto 27