title: Accuracy of capsule colonoscopy in detecting colorectal polyps in a screening population.
abstract: OBJECTIVE
  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.affiliation: Department of Medicine, Division of Gastroenterology/Hepatology, Indiana University Hospital, Indianapolis, Indiana. Electronic address: drex@iupui.edu.
authors.forename: Douglas K
authors.initials: DK
authors.lastname: Rex
authors.affiliation: Digestive Diseases Institute, Shaare Zedek Medical Center, Jerusalem, Israel.
authors.forename: Samuel N
authors.initials: SN
authors.lastname: Adler
authors.affiliation: Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
authors.forename: James
authors.initials: J
authors.lastname: Aisenberg
authors.affiliation: Franklin Gastroenterology, PLLC, Franklin, Tennessee.
authors.forename: Wilmot C
authors.initials: WC
authors.lastname: Burch
authors.affiliation: Departamento de Digestivo Clinica Universidad de Navarra, Pamplona, Spain.
authors.forename: Cristina
authors.initials: C
authors.lastname: Carretero
authors.affiliation: Division of Internal Medicine, Gastroenterology Institute, Rambam Health Care Campus, Haifa, Israel.
authors.forename: Yehuda
authors.initials: Y
authors.lastname: Chowers
authors.affiliation: Pasadena Gastroenterology Associates, PA, Pasadena, Texas.
authors.forename: Steven A
authors.initials: SA
authors.lastname: Fein
authors.affiliation: Specialists in Gastroenterology, Creve Coeur, Missouri.
authors.forename: Steven E
authors.initials: SE
authors.lastname: Fern
authors.affiliation: Department of Gastroenterology, Servicio de Digestivo, Hospital de Navarra, Pamplona, Spain.
authors.forename: Ignacio
authors.initials: I
authors.lastname: Fernandez-Urien Sainz
authors.affiliation: Department of Gastroenterology and Hepatology, Soroka University Medical Center, Beer-Sheva, Israel.
authors.forename: Alexander
authors.initials: A
authors.lastname: Fich
authors.affiliation: Gastroenterology Department, Rabin Medical Center, Beilinson Hospital, Petah-Tikva, Israel.
authors.forename: Eyal
authors.initials: E
authors.lastname: Gal
authors.affiliation: Louisville Gastroenterology Associates, PLLC, Lousiville, Kentucky.
authors.forename: John C
authors.initials: JC
authors.lastname: Horlander
authors.affiliation: Department of Medicine, Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, North Carolina.
authors.forename: Kim L
authors.initials: KL
authors.lastname: Isaacs
authors.affiliation: The Research Center for Digestive Tract and Liver Diseases, The Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel.
authors.forename: Revital
authors.initials: R
authors.lastname: Kariv
authors.affiliation: Department of Gastroenterology, Chaim Sheba Medical Center, Tel-Hashomer, Israel.
authors.forename: Adi
authors.initials: A
authors.lastname: Lahat
authors.affiliation: Department of Medicine, Division of Gastroenterology & Hepatology, Department of Medicine, University of Hong Kong, Hong Kong, China.
authors.forename: Wai-Keung
authors.initials: WK
authors.lastname: Leung
authors.affiliation: Gastroenterology Associates of Tidewater, PC, Chesapeake, Virginia.
authors.forename: Pramod R
authors.initials: PR
authors.lastname: Malik
authors.affiliation: Department of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, Vanderbilt Institute for Global Health, Vanderbilt University, Nashville, Tennessee.
authors.forename: Doug
authors.initials: D
authors.lastname: Morgan
authors.affiliation: Department of Gastroenterology and Hepatology, Sheba Medical Center Tel Hashomer, Ramat Gan, Israel.
authors.forename: Neofytos
authors.initials: N
authors.lastname: Papageorgiou
authors.affiliation: Dayton Gastroenterology, Inc, Beavercreek, Ohio.
authors.forename: David P
authors.initials: DP
authors.lastname: Romeo
authors.affiliation: Alabama Digestive Disorders Center, PC, Huntsville, Alabama.
authors.forename: Smita S
authors.initials: SS
authors.lastname: Shah
authors.affiliation: Division of Internal Medicine, Gastroenterology Institute, Rambam Health Care Campus, Haifa, Israel.
authors.forename: Matti
authors.initials: M
authors.lastname: Waterman
mesh_terms: D018256:Adenomatous Polyps / Q000473:pathology*; D053704:Capsule Endoscopy / Q000009:adverse effects / Q000379:methods*; D003111:Colonic Polyps / Q000473:pathology*; D003113:Colonoscopy / Q000009:adverse effects / Q000379:methods*; D015179:Colorectal Neoplasms / Q000473:pathology*; D005188:False Negative Reactions; D005260:Female; D006801:Humans; D006965:Hyperplasia; D007417:Intestinal Polyps / Q000473:pathology*; D007557:Israel; D008297:Male; D008403:Mass Screening / Q000009:adverse effects / Q000379:methods*; D008875:Middle Aged; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012002:Rectal Diseases / Q000473:pathology*; D047368:Tumor Burden; D014481:United States
keywords: Colon Cancer Detection; Colorectal Lesion; Diagnosis; Neoplasm; Tumor