Evaluation of the clinical efficacy of colon capsule endoscopy in the detection of lesions of the colon: prospective, multicenter, open study.
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.


METHODS
A prospective, open-label, clinical study in Japan.


METHODS
Multicenter.


METHODS
Patients referred for OC because of personal history of polyps ≥6 mm or any other colon lesion that required endoscopic or surgical treatment.


METHODS
CCE followed by therapeutic colonoscopy.


METHODS
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.


CONCLUSIONS
All patients had previously confirmed colon lesions, which may have falsely elevated the sensitivity of CCE.


CONCLUSIONS
CCE had a high sensitivity for detecting significant colon lesions. CCE was safe and had a high level of patient acceptability. (


BACKGROUND
University Hospital Medical Information Network, UMIN000007258.).
Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan.
Yutaka
Y
Saito
Division of Gastroenterology and Hepatology/Endoscopy, Tokyo Jikei University School of Medicine, Tokyo, Japan.
Shoichi
S
Saito
Department of Endoscopy, Hiroshima University Hospital, Hiroshima, Japan.
Shiro
S
Oka
Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan.
Yasuo
Y
Kakugawa
Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan.
Minori
M
Matsumoto
Division of Gastroenterology and Hepatology/Endoscopy, Tokyo Jikei University School of Medicine, Tokyo, Japan.
Hiroyuki
H
Aihara
Department of Endoscopy, Hiroshima University Hospital, Hiroshima, Japan.
Ikue
I
Watari
Department of Endoscopy, Hiroshima University Hospital, Hiroshima, Japan.
Taiki
T
Aoyama
The 2nd Department of Internal Medicine, Osaka Medical College, Osaka, Japan.
Sadaharu
S
Nouda
The 2nd Department of Internal Medicine, Osaka Medical College, Osaka, Japan.
Takanori
T
Kuramoto
Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan.
Kenji
K
Watanabe
Department of Internal Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan (Presently Educational Corporation Fujita School, Fujita Health University Hospital).
Naoki
N
Ohmiya
The 2nd Department of Internal Medicine, Osaka Medical College, Osaka, Japan.
Kazuhide
K
Higuchi
Department of Internal Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan (Presently Educational Corporation Fujita School, Fujita Health University Hospital).
Hidemi
H
Goto
Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan.
Tetsuo
T
Arakawa
Department of Endoscopy, Hiroshima University Hospital, Hiroshima, Japan.
Shinji
S
Tanaka
Division of Gastroenterology and Hepatology/Endoscopy, Tokyo Jikei University School of Medicine, Tokyo, Japan.
Hisao
H
Tajiri
D053704:Capsule Endoscopy / Q000379:methods*; D003106:Colon / Q000473:pathology*; D003111:Colonic Polyps / Q000175:diagnosis* / Q000601:surgery; D003113:Colonoscopy; D003937:Diagnosis, Differential; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015203:Reproducibility of Results