Yutaka Saito1, Shoichi Saito2, Shiro Oka3, Yasuo Kakugawa1, Minori Matsumoto1, Hiroyuki Aihara2, Ikue Watari3, Taiki Aoyama3, Sadaharu Nouda4, Takanori Kuramoto4, Kenji Watanabe5, Naoki Ohmiya6, Kazuhide Higuchi4, Hidemi Goto6, Tetsuo Arakawa5, Shinji Tanaka3, Hisao Tajiri2. 1. Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan. 2. Division of Gastroenterology and Hepatology/Endoscopy, Tokyo Jikei University School of Medicine, Tokyo, Japan. 3. Department of Endoscopy, Hiroshima University Hospital, Hiroshima, Japan. 4. The 2nd Department of Internal Medicine, Osaka Medical College, Osaka, Japan. 5. Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan. 6. Department of Internal Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan (Presently Educational Corporation Fujita School, Fujita Health University Hospital).
Abstract
BACKGROUND:Colon capsule endoscopy (CCE) is a new procedure for colon imaging. Limited information is available regarding visualization of flat colon lesions and patient acceptability in Japan. OBJECTIVE: The aims of this study were to evaluate the sensitivity of CCE in detecting polyps and other lesions compared with optical colonoscopy (OC) and to evaluate its safety and acceptability in a cohort of Japanese patients. DESIGN: A prospective, open-label, clinical study in Japan. SETTING: Multicenter. PATIENTS: Patients referred for OC because of personal history of polyps ≥6 mm or any other colon lesion that required endoscopic or surgical treatment. INTERVENTIONS:CCE followed by therapeutic colonoscopy. MAIN OUTCOME MEASUREMENTS: The primary endpoint was per-patient sensitivity of CCE in detecting significant colon lesion. The secondary endpoints were CCE safety and patient acceptability. RESULTS:Sixty-six of the 72 patients enrolled in the study were evaluated for efficacy. The per-patient sensitivity was 94% (95% confidence interval [CI], 88.2%-99.7%). The per-polyp sensitivity was 86.6% (95% CI, 81.3%-91.9%) when pathology-confirmed polyps were considered true positives. There were no adverse events related to CCE, and the acceptability of CCE was high. LIMITATIONS: All patients had previously confirmed colon lesions, which may have falsely elevated the sensitivity of CCE. CONCLUSION:CCE had a high sensitivity for detecting significant colon lesions. CCE was safe and had a high level of patient acceptability. ( CLINICAL TRIAL REGISTRATION NUMBER: University Hospital Medical Information Network, UMIN000007258.).
RCT Entities:
BACKGROUND: Colon capsule endoscopy (CCE) is a new procedure for colon imaging. Limited information is available regarding visualization of flat colon lesions and patient acceptability in Japan. OBJECTIVE: The aims of this study were to evaluate the sensitivity of CCE in detecting polyps and other lesions compared with optical colonoscopy (OC) and to evaluate its safety and acceptability in a cohort of Japanese patients. DESIGN: A prospective, open-label, clinical study in Japan. SETTING: Multicenter. PATIENTS: Patients referred for OC because of personal history of polyps ≥6 mm or any other colon lesion that required endoscopic or surgical treatment. INTERVENTIONS:CCE followed by therapeutic colonoscopy. MAIN OUTCOME MEASUREMENTS: The primary endpoint was per-patient sensitivity of CCE in detecting significant colon lesion. The secondary endpoints were CCE safety and patient acceptability. RESULTS: Sixty-six of the 72 patients enrolled in the study were evaluated for efficacy. The per-patient sensitivity was 94% (95% confidence interval [CI], 88.2%-99.7%). The per-polyp sensitivity was 86.6% (95% CI, 81.3%-91.9%) when pathology-confirmed polyps were considered true positives. There were no adverse events related to CCE, and the acceptability of CCE was high. LIMITATIONS: All patients had previously confirmed colon lesions, which may have falsely elevated the sensitivity of CCE. CONCLUSION:CCE had a high sensitivity for detecting significant colon lesions. CCE was safe and had a high level of patient acceptability. ( CLINICAL TRIAL REGISTRATION NUMBER: University Hospital Medical Information Network, UMIN000007258.).
Authors: Johannes Hausmann; Jan-Peter Linke; Jörg G Albert; Johannes Masseli; Andrea Tal; Alica Kubesch; Natalie Filmann; Michael Philipper; Michael Farnbacher Journal: Int J Colorectal Dis Date: 2019-09-13 Impact factor: 2.571