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.

Automated summary

This study assessed the false negative rate of CCE and the breakdown of reader/technical errors. The results showed that CCE has a significant false negative rate, which should be taken into consideration in clinical decision making.