Accuracy of Capsule Colonoscopy in Detecting Colorectal Polyps in a Screening Population

• Published in: Gastroenterology (New York, N.Y. 1943) Vol. 148; no. 5; pp. 948 - 957.e2
• Main Authors: Rex, Douglas K., Adler, Samuel N., Aisenberg, James, Burch, Wilmot C., Carretero, Cristina, Chowers, Yehuda, Fein, Steven A., Fern, Steven E., Fernandez-Urien Sainz, Ignacio, Fich, Alexander, Gal, Eyal, Horlander, John C., Isaacs, Kim L., Kariv, Revital, Lahat, Adi, Leung, Wai-Keung, Malik, Pramod R., Morgan, Doug, Papageorgiou, Neofytos, Romeo, David P., Shah, Smita S., Waterman, Matti
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.05.2015
• Subjects: Adenomatous Polyps - pathology; Capsule Endoscopy - adverse effects; Capsule Endoscopy - methods; Colon Cancer Detection; Colonic Polyps - pathology; Colonoscopy - adverse effects; Colonoscopy - methods; Colorectal Lesion; Colorectal Neoplasms - pathology; Diagnosis; False Negative Reactions; Female; Gastroenterology and Hepatology; Humans; Hyperplasia; Intestinal Polyps - pathology; Israel; Male; Mass Screening - adverse effects; Mass Screening - methods; Middle Aged; Neoplasm; Predictive Value of Tests; Prospective Studies; Rectal Diseases - pathology; Tumor; Tumor Burden; United States; United States; Israel; Colorectal Lesion; Neoplasm; CT; CTC; Colon Cancer Detection; CRC; CI; Tumor; Diagnosis; ADR; computed tomography; colorectal cancer; adenoma detection rate; confidence interval; computed tomography colonography
• ISSN: 0016-5085; 1528-0012; 1528-0012
• DOI: 10.1053/j.gastro.2015.01.025

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. 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. 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. 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.