Douglas K Rex1, Samuel N Adler2, James Aisenberg3, Wilmot C Burch4, Cristina Carretero5, Yehuda Chowers6, Steven A Fein7, Steven E Fern8, Ignacio Fernandez-Urien Sainz9, Alexander Fich10, Eyal Gal11, John C Horlander12, Kim L Isaacs13, Revital Kariv14, Adi Lahat15, Wai-Keung Leung16, Pramod R Malik17, Doug Morgan18, Neofytos Papageorgiou19, David P Romeo20, Smita S Shah21, Matti Waterman6. 1. Department of Medicine, Division of Gastroenterology/Hepatology, Indiana University Hospital, Indianapolis, Indiana. Electronic address: drex@iupui.edu. 2. Digestive Diseases Institute, Shaare Zedek Medical Center, Jerusalem, Israel. 3. Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York. 4. Franklin Gastroenterology, PLLC, Franklin, Tennessee. 5. Departamento de Digestivo Clinica Universidad de Navarra, Pamplona, Spain. 6. Division of Internal Medicine, Gastroenterology Institute, Rambam Health Care Campus, Haifa, Israel. 7. Pasadena Gastroenterology Associates, PA, Pasadena, Texas. 8. Specialists in Gastroenterology, Creve Coeur, Missouri. 9. Department of Gastroenterology, Servicio de Digestivo, Hospital de Navarra, Pamplona, Spain. 10. Department of Gastroenterology and Hepatology, Soroka University Medical Center, Beer-Sheva, Israel. 11. Gastroenterology Department, Rabin Medical Center, Beilinson Hospital, Petah-Tikva, Israel. 12. Louisville Gastroenterology Associates, PLLC, Lousiville, Kentucky. 13. Department of Medicine, Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, North Carolina. 14. The Research Center for Digestive Tract and Liver Diseases, The Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel. 15. Department of Gastroenterology, Chaim Sheba Medical Center, Tel-Hashomer, Israel. 16. Department of Medicine, Division of Gastroenterology & Hepatology, Department of Medicine, University of Hong Kong, Hong Kong, China. 17. Gastroenterology Associates of Tidewater, PC, Chesapeake, Virginia. 18. Department of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, Vanderbilt Institute for Global Health, Vanderbilt University, Nashville, Tennessee. 19. Department of Gastroenterology and Hepatology, Sheba Medical Center Tel Hashomer, Ramat Gan, Israel. 20. Dayton Gastroenterology, Inc, Beavercreek, Ohio. 21. Alabama Digestive Disorders Center, PC, Huntsville, Alabama.
Abstract
BACKGROUND & AIMS: Capsule colonoscopy is a minimally invasive imaging method. We measured the accuracy of this technology in detecting polyps 6 mm or larger in an average-risk screening population. METHODS: In a prospective study, asymptomatic subjects (n = 884) underwent capsule colonoscopy followed by conventional colonoscopy (the reference) several weeks later, with an endoscopist blinded to capsule results, at 10 centers in the United States and 6 centers in Israel from June 2011 through April 2012. An unblinded colonoscopy was performed on subjects found to have lesions 6 mm or larger by capsule but not conventional colonoscopy. RESULTS: Among the 884 subjects enrolled, 695 (79%) were included in the analysis of capsule performance for all polyps. There were 77 exclusions (9%) for inadequate cleansing and whole-colon capsule transit time fewer than 40 minutes, 45 exclusions (5%) before capsule ingestion, 15 exclusions (2%) after ingestion and before colonoscopy, and 15 exclusions (2%) for site termination. Capsule colonoscopy identified subjects with 1 or more polyps 6 mm or larger with 81% sensitivity (95% confidence interval [CI], 77%-84%) and 93% specificity (95% CI, 91%-95%), and polyps 10 mm or larger with 80% sensitivity (95% CI, 74%-86%) and 97% specificity (95% CI, 96%-98%). Capsule colonoscopy identified subjects with 1 or more conventional adenomas 6 mm or larger with 88% sensitivity (95% CI, 82%-93) and 82% specificity (95% CI, 80%-83%), and 10 mm or larger with 92% sensitivity (95% CI, 82%-97%) and 95% specificity (95% CI, 94%-95%). Sessile serrated polyps and hyperplastic polyps accounted for 26% and 37%, respectively, of false-negative findings from capsule analyses. CONCLUSIONS: In an average-risk screening population, technically adequate capsule colonoscopy identified individuals with 1 or more conventional adenomas 6 mm or larger with 88% sensitivity and 82% specificity. Capsule performance seems adequate for patients who cannot undergo colonoscopy or who had incomplete colonoscopies. Additional studies are needed to improve capsule detection of serrated lesions. Clinicaltrials.gov number: NCT01372878.
BACKGROUND & AIMS: Capsule colonoscopy is a minimally invasive imaging method. We measured the accuracy of this technology in detecting polyps 6 mm or larger in an average-risk screening population. METHODS: In a prospective study, asymptomatic subjects (n = 884) underwent capsule colonoscopy followed by conventional colonoscopy (the reference) several weeks later, with an endoscopist blinded to capsule results, at 10 centers in the United States and 6 centers in Israel from June 2011 through April 2012. An unblinded colonoscopy was performed on subjects found to have lesions 6 mm or larger by capsule but not conventional colonoscopy. RESULTS: Among the 884 subjects enrolled, 695 (79%) were included in the analysis of capsule performance for all polyps. There were 77 exclusions (9%) for inadequate cleansing and whole-colon capsule transit time fewer than 40 minutes, 45 exclusions (5%) before capsule ingestion, 15 exclusions (2%) after ingestion and before colonoscopy, and 15 exclusions (2%) for site termination. Capsule colonoscopy identified subjects with 1 or more polyps 6 mm or larger with 81% sensitivity (95% confidence interval [CI], 77%-84%) and 93% specificity (95% CI, 91%-95%), and polyps 10 mm or larger with 80% sensitivity (95% CI, 74%-86%) and 97% specificity (95% CI, 96%-98%). Capsule colonoscopy identified subjects with 1 or more conventional adenomas 6 mm or larger with 88% sensitivity (95% CI, 82%-93) and 82% specificity (95% CI, 80%-83%), and 10 mm or larger with 92% sensitivity (95% CI, 82%-97%) and 95% specificity (95% CI, 94%-95%). Sessile serrated polyps and hyperplastic polyps accounted for 26% and 37%, respectively, of false-negative findings from capsule analyses. CONCLUSIONS: In an average-risk screening population, technically adequate capsule colonoscopy identified individuals with 1 or more conventional adenomas 6 mm or larger with 88% sensitivity and 82% specificity. Capsule performance seems adequate for patients who cannot undergo colonoscopy or who had incomplete colonoscopies. Additional studies are needed to improve capsule detection of serrated lesions. Clinicaltrials.gov number: NCT01372878.
Authors: David Kastenberg; Wilmot C Burch; David P Romeo; Pankaj K Kashyap; David C Pound; Neophytos Papageorgiou; Ignacio Fernández-Urien Sainz; Carly E Sokach; Douglas K Rex Journal: World J Gastroenterol Date: 2017-12-28 Impact factor: 5.742
Authors: Ernst J Kuipers; William M Grady; David Lieberman; Thomas Seufferlein; Joseph J Sung; Petra G Boelens; Cornelis J H van de Velde; Toshiaki Watanabe Journal: Nat Rev Dis Primers Date: 2015-11-05 Impact factor: 52.329