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


      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.


      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.


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




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


      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.


      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.


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


      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.)


      CCE (colon capsule endoscopy), LST (laterally spreading tumor), OC (optical colonoscopy)
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        • Nishihara R.
        • Wu K.
        • Lochhead P.
        • et al.
        Long-term colorectal-cancer incidence and mortality after lower endoscopy.
        N Engl J Med. 2013; 369: 1095-1105
        • Zauber A.G.
        • Winawer S.J.
        • O’Brien M.J.
        • et al.
        Colonoscopic polypectomy and long-term prevention of colorectal–cancer deaths.
        N Engl J Med. 2012; 366: 687-696
      1. The 2011 National Summary of Gastrointestinal Cancer Screening. Commission report of the Japanese Society of Gastrointestinal Cancer Screening.

        • Negreanu L.
        • Babiuc R.
        • Bengus A.
        • et al.
        PillCam Colon 2 capsule in patients unable or unwilling to undergo colonoscopy.
        World J Gastrointest Endosc. 2013; 5: 559-567
        • Eliakim R.
        • Fireman Z.
        • Gralnek I.M.
        • et al.
        Evaluation of the PillCam Colon capsule in the detection of colonic pathology: results of the first multicenter, prospective, comparative study.
        Endoscopy. 2006; 38: 963-970
        • Schoofs N.
        • Deviere J.
        • Van Gossum A.
        PillCam colon capsule endoscopy compared with colonoscopy for colorectal tumor diagnosis: a prospective pilot study.
        Endoscopy. 2006; 38: 971-977
        • Sieg A.
        • Friedrich K.
        • Sieg U.
        Is PillCam COLON capsule endoscopy ready for colorectal cancer screening? A prospective feasibility study in a community gastroenterology practice.
        Am J Gastroenterol. 2009; 104: 848-854
        • Van Gossum A.
        • Navas M.M.
        • Fernandez-Urien I.
        • et al.
        Capsule endoscopy versus colonoscopy for the detection of polyps and cancer.
        N Engl J Med. 2009; 361: 264-270
        • Gay G.
        • Delvaux M.
        • Frederic M.
        • et al.
        Could the colonic capsule PillCam Colon be clinically useful for selecting patients who deserve a complete colonoscopy? Results of clinical comparison with colonoscopy in the perspective of colorectal cancer screening.
        Am J Gastroenterol. 2010; 105: 1076-1086
        • Sacher-Huvelin S.
        • Coron E.
        • Gaudric M.
        • et al.
        Colon capsule endoscopy vs. colonoscopy in patients at average or increased risk of colorectal cancer.
        Aliment Pharmacol Ther. 2010; 32: 1145-1153
        • Pilz J.B.
        • Portmann S.
        • Peter S.
        • et al.
        Colon capsule endoscopy compared to conventional colonoscopy under routine screening conditions.
        BMC Gastroenterol. 2010; 10: 66
        • Spada C.
        • De Vincentis F.
        • Cesaro P.
        • et al.
        Accuracy and safety of second-generation PillCam COLON capsule for colorectal polyp detection.
        Therap Adv Gastroenterol. 2012; 5: 173-178
        • Eliakim R.
        • Yassin K.
        • Niv Y.
        • et al.
        Prospective multicenter performance evaluation of the second-generation colon capsule compared with colonoscopy.
        Endoscopy. 2009; 41: 1026-1031
        • Spada C.
        • Riccioni M.E.
        • Hassan C.
        • et al.
        PillCam colon capsule endoscopy: a prospective, randomized trial comparing two regimens of preparation.
        J Clin Gastroenterol. 2011; 45: 119-124
        • Hartmann D.
        • Keuchel M.
        • Philipper M.
        • et al.
        A pilot study evaluating a new low-volume colon cleansing procedure for capsule colonoscopy.
        Endoscopy. 2012; 44: 482-486
        • Hagel A.F.
        • Gabele E.
        • Raithel M.
        • et al.
        Colon capsule endoscopy: detection of colonic polyps compared with conventional colonoscopy and visualization of extracolonic pathologies.
        Can J Gastroenterol Hepatol. 2014; 28: 77-82
        • Spada C.
        • Hassan C.
        • Munoz-Navas M.
        • et al.
        Second-generation colon capsule endoscopy compared with colonoscopy.
        Gastrointest Endosc. 2011; 74: 581-589 e1
        • Singeap A.M.
        • Trifan A.
        • Cojocariu C.
        • et al.
        Colon capsule endoscopy compared to colonoscopy for colorectal neoplasms diagnosis: an initial experience and a brief review of the literature.
        Rev Med Chir Soc Med Nat Iasi. 2012; 116: 145-149
        • Kakugawa Y.
        • Saito Y.
        • Saito S.
        • et al.
        New reduced volume preparation regimen in colon capsule endoscopy.
        World J Gastroenterol. 2012; 18: 2092-2098
        • Spada C.
        • Hassan C.
        • Galmiche J.P.
        • et al.
        Colon capsule endoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline.
        Endoscopy. 2012; 44: 527-536
        • Urakawa T.
        • Saito Y.
        • Matsuda T.
        • et al.
        Endoscopic indications for endoscopic mucosal resection of laterally spreading tumors in the colorectum.
        Gut. 2006; 55: 1592-1597
      2. The 2005 Group for study for appropriate methods for cancer screening and establishment of its evaluation method. Colonic cancer screening guideline based on efficacy.

        • Saito Y.
        • Uraoka T.
        • Yamaguchi Y.
        • et al.
        A prospective multicenter study of 1111 colorectal endoscopic submucosal dissections (with video).
        Gastrointest Endosc. 2010; 72: 1217-1225
        • Nakajima T.
        • Saito Y.
        • Tanaka S.
        • et al.
        Current status of endoscopic resection strategy for large, early colorectal neoplasia in Japan.
        Surg Endosc. 2013; 27: 3262-3270
        • Saito Y.
        • Otake Y.
        • Sakamoto T.
        • et al.
        Indications for and technical aspects of colorectal endoscopic submucosal dissection.
        Gut Liver. 2013; 7: 263-269