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New-generation full-spectrum endoscopy versus standard forward-viewing colonoscopy: a multicenter, randomized, tandem colonoscopy trial (J-FUSE Study) - 10/10/18

Doi : 10.1016/j.gie.2018.06.011 
Toyoki Kudo, MD, PhD 1, ⁎, Yutaka Saito, MD, PhD 2, Hiroaki Ikematsu, MD, PhD 3, Kinichi Hotta, MD 4, Yoji Takeuchi, MD 5, Masaaki Shimatani, MD, PhD 6, Ken Kawakami, MD, PhD 7, Naoto Tamai, MD, PhD 8, Yuichi Mori, MD, PhD 1, Yasuharu Maeda, MD, PhD 1, Masayoshi Yamada, MD, PhD 2, Taku Sakamoto, MD 2, Takahisa Matsuda, MD, PhD 2, Kenichiro Imai, MD 4, Sayo Ito, MD 4, Kenta Hamada, MD 5, Norimasa Fukata, MD, PhD 6, Takuya Inoue, MD, PhD 7, Hisao Tajiri, MD, PhD 9, Kenichi Yoshimura, PhD 10, Hideki Ishikawa, MD, PhD 11, Shin-ei Kudo, MD, PhD 1
1 Digestive Disease Center, Showa University Northern Yokohama Hospital, Yokohama, Japan 
2 Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan 
3 Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Chiba, Japan 
4 Division of Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan 
5 Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan 
6 Third Department of Internal Medicine, Division of Gastroenterology and Hepatology, Kansai Medical University, Osaka, Japan 
7 Second Department of Internal Medicine, Osaka Medical College, Osaka, Japan 
8 Department of Endoscopy, Jikei University School of Medicine, Tokyo, Japan 
9 Department of Innovative Interventional Endoscopy Research, Jikei University School of Medicine, Tokyo, Japan 
10 Innovative Clinical Research Center, Kanazawa University Hospital, Kanazawa, Japan 
11 Department of Molecular-Targeting Cancer Prevention, Kyoto Prefectural University of Medicine, Kyoto, Japan 

∗Reprint requests: Toyoki Kudo, MD, PhD, Digestive Disease Centre, Showa University Northern Yokohama Hospital, 35-1 Chigasaki-chuo, Tsuzuki-ku, Yokohama 224-8503, Japan.Digestive Disease CentreShowa University Northern Yokohama Hospital35-1 Chigasaki-chuoTsuzuki-kuYokohama224-8503Japan

Abstract

Background and Aims

Although 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.

Methods

We 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).

Results

We 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).

Conclusions

FUSE 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.)

Il testo completo di questo articolo è disponibile in PDF.

Abbreviations : ADR, AMR, AMR-PP, CRC, EU, FUSE, PMR, PMR-PP, SCIR, SFVC


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 DISCLOSURE: The following author disclosed financial relationships relevant to this publication: S. Kudo: Consultant for and study funding from Adachi Corporation. All other authors disclosed no financial relationships relevant to this publication. Research support for this study was provided by Adachi, Osaka, Japan.
 See CME section, p. 868.
 If you would like to chat with an author of this article, you may contact Dr Kudo at s6027@nms.ac.jp.


© 2018  American Society for Gastrointestinal Endoscopy. Pubblicato da Elsevier Masson SAS. Tutti i diritti riservati.
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Vol 88 - N° 5

P. 854-864 - novembre 2018 Ritorno al numero
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