• Gastrointest. Endosc. · Nov 2018

    Randomized Controlled Trial Multicenter Study Comparative Study

    New-generation full-spectrum endoscopy versus standard forward-viewing colonoscopy: a multicenter, randomized, tandem colonoscopy trial (J-FUSE Study).

    • Toyoki Kudo, Yutaka Saito, Hiroaki Ikematsu, Kinichi Hotta, Yoji Takeuchi, Masaaki Shimatani, Ken Kawakami, Naoto Tamai, Yuichi Mori, Yasuharu Maeda, Masayoshi Yamada, Taku Sakamoto, Takahisa Matsuda, Kenichiro Imai, Sayo Ito, Kenta Hamada, Norimasa Fukata, Takuya Inoue, Hisao Tajiri, Kenichi Yoshimura, Hideki Ishikawa, and Shin-Ei Kudo.
    • Digestive Disease Center, Showa University Northern Yokohama Hospital, Yokohama, Japan.
    • Gastrointest. Endosc. 2018 Nov 1; 88 (5): 854-864.

    Background And AimsAlthough colonoscopy is the criterion standard for detection of colorectal adenomas, some adenomas are missed. Full-spectrum endoscopy (FUSE) allows for observation with a 330-degree angle of view, which is expected to decrease the miss rate. However, no consensus has been reached regarding the superiority of FUSE over standard forward-viewing colonoscopy (SFVC) for detection of adenomas; we therefore compared new-generation FUSE and SFVC regarding colorectal adenoma miss rate (AMR) in this, the first reported randomized control trial using new-generation FUSE.MethodsWe enrolled individuals aged 40 to 75 years who had been referred for screening, surveillance, fecal occult blood test positivity, or symptoms in a prospective randomized trial of tandem colonoscopy in 8 institutions. Patients were randomly assigned (1:1) via computer-generated stratified randomization. Neither the endoscopists nor patients were blinded to the allocation. The primary endpoint was AMR per patient (AMR-PP).ResultsWe enrolled 345 patients and included 319 in the per-protocol analyses. AMR-PP was significantly lower with FUSE (11.7%; 95% confidence interval [CI], 8.0%-15.4%) than with SFVC (22.9%; 95% CI, 17.5%-28.3%; P < .001). AMR-PP for lesions ≤5 mm in size was significantly lower with FUSE (10.4%; 95% CI, 6.5%-14.3%) than with SFVC (20.0%; 95% CI, 14.4%-25.6%; P = .0057). Furthermore, AMR-PP in the ascending colon was significantly lower with FUSE (4.3%; 95% CI, 1.4%-7.2%) than with SFVC (10.6%; 95% CI, 6.1%-15.1%; P = .0212).ConclusionsFUSE is superior to SFVC regarding both AMR-PP and AMR; additionally, AMR-PP is both significantly lower with FUSE than SFVC for lesions ≤5 mm in size and in the ascending colon. (Clinical trial registration number: UMIN000020448.).Copyright © 2018 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

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