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

Yutaka Saito, Shoichi Saito, Shiro Oka, Yasuo Kakugawa, Minori Matsumoto, Hiroyuki Aihara, Ikue Watari, Taiki Aoyama, Sadaharu Nouda, Takanori Kuramoto, Kenji Watanabe, Naoki Ohmiya, Kazuhide Higuchi, Hidemi Goto, Tetsuo Arakawa, Shinji Tanaka, Hisao Tajiri

Research output: Contribution to journalArticle

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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.)

Original languageEnglish
Pages (from-to)861-869
Number of pages9
JournalGastrointestinal Endoscopy
Volume82
Issue number5
DOIs
Publication statusPublished - 11-2015

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Capsule Endoscopy
Multicenter Studies
Colon
Polyps
Colonoscopy
Japan
Confidence Intervals
Information Services

All Science Journal Classification (ASJC) codes

  • Radiology Nuclear Medicine and imaging
  • Gastroenterology

Cite this

Saito, Yutaka ; Saito, Shoichi ; Oka, Shiro ; Kakugawa, Yasuo ; Matsumoto, Minori ; Aihara, Hiroyuki ; Watari, Ikue ; Aoyama, Taiki ; Nouda, Sadaharu ; Kuramoto, Takanori ; Watanabe, Kenji ; Ohmiya, Naoki ; Higuchi, Kazuhide ; Goto, Hidemi ; Arakawa, Tetsuo ; Tanaka, Shinji ; Tajiri, Hisao. / Evaluation of the clinical efficacy of colon capsule endoscopy in the detection of lesions of the colon : Prospective, multicenter, open study. In: Gastrointestinal Endoscopy. 2015 ; Vol. 82, No. 5. pp. 861-869.
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title = "Evaluation of the clinical efficacy of colon capsule endoscopy in the detection of lesions of the colon: Prospective, multicenter, open study",
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.)",
author = "Yutaka Saito and Shoichi Saito and Shiro Oka and Yasuo Kakugawa and Minori Matsumoto and Hiroyuki Aihara and Ikue Watari and Taiki Aoyama and Sadaharu Nouda and Takanori Kuramoto and Kenji Watanabe and Naoki Ohmiya and Kazuhide Higuchi and Hidemi Goto and Tetsuo Arakawa and Shinji Tanaka and Hisao Tajiri",
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Saito, Y, Saito, S, Oka, S, Kakugawa, Y, Matsumoto, M, Aihara, H, Watari, I, Aoyama, T, Nouda, S, Kuramoto, T, Watanabe, K, Ohmiya, N, Higuchi, K, Goto, H, Arakawa, T, Tanaka, S & Tajiri, H 2015, 'Evaluation of the clinical efficacy of colon capsule endoscopy in the detection of lesions of the colon: Prospective, multicenter, open study', Gastrointestinal Endoscopy, vol. 82, no. 5, pp. 861-869. https://doi.org/10.1016/j.gie.2015.02.004

Evaluation of the clinical efficacy of colon capsule endoscopy in the detection of lesions of the colon : Prospective, multicenter, open study. / Saito, Yutaka; Saito, Shoichi; Oka, Shiro; Kakugawa, Yasuo; Matsumoto, Minori; Aihara, Hiroyuki; Watari, Ikue; Aoyama, Taiki; Nouda, Sadaharu; Kuramoto, Takanori; Watanabe, Kenji; Ohmiya, Naoki; Higuchi, Kazuhide; Goto, Hidemi; Arakawa, Tetsuo; Tanaka, Shinji; Tajiri, Hisao.

In: Gastrointestinal Endoscopy, Vol. 82, No. 5, 11.2015, p. 861-869.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Evaluation of the clinical efficacy of colon capsule endoscopy in the detection of lesions of the colon

T2 - Prospective, multicenter, open study

AU - Saito, Yutaka

AU - Saito, Shoichi

AU - Oka, Shiro

AU - Kakugawa, Yasuo

AU - Matsumoto, Minori

AU - Aihara, Hiroyuki

AU - Watari, Ikue

AU - Aoyama, Taiki

AU - Nouda, Sadaharu

AU - Kuramoto, Takanori

AU - Watanabe, Kenji

AU - Ohmiya, Naoki

AU - Higuchi, Kazuhide

AU - Goto, Hidemi

AU - Arakawa, Tetsuo

AU - Tanaka, Shinji

AU - Tajiri, Hisao

PY - 2015/11

Y1 - 2015/11

N2 - 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.)

AB - 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.)

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