Low Colon Capsule Endoscopy (CCE) False Negative Rate for Polyps Excluding Reader Error

Background: CCE is a diagnostic tool lacking clinical data on false negative rates. We aimed to assess this rate and the reader/technical error breakdown. Methods: False negative CCEs were identified after comparing to a colonoscopy database. Missed pathology characteristics and study indications/quality were collated. Cases were re-read by experts and newly identified lesions/pathologies were verified by an expert panel and categorised as reader/technical errors. Results: Of 532 CCEs, 203 had an adequately reported comparative colonoscopy, 45 (22.2%) had missed polyps, and 26/45 (57.8%) reached the colonic section with missed pathology. Of the cases, 22 (84.6%) had adequate bowel preparation. Indications included 13 (50%) polyp surveillance, 12 (46%) GI symptoms, 1 (4%) polyp screening. CCE missed 18 (69.2%) diminutive polyps and 8 (30.8%) polyps ≥ 6 mm, 18/26 (69.2%) of these were adenomas. Excluding incomplete CCE correlates, colonoscopy total and significant polyp yield were 97/184 (52.7%) and 50/97 (51.5%), respectively. CCE total polyp and significant polyp false negative rate was 26.8% (26/97) and 16% (8/50), respectively. Following re-reading, reader and technical error was 20/26 (76.9%) and 6/26 (23.1%). Total and significant missed polyp rates were 20.6% (20/97) and 14% (7/50) for reader error, 6.2% (6/97) and 2% (1/50) for technical error. Conclusions: False negative CCE rate is not insubstantial and should be factored into clinical decision making.