Toyoki Kudo1, Yutaka Saito2, Hiroaki Ikematsu3, Kinichi Hotta4, Yoji Takeuchi5, Masaaki Shimatani6, Ken Kawakami7, Naoto Tamai8, Yuichi Mori1, Yasuharu Maeda1, Masayoshi Yamada2, Taku Sakamoto2, Takahisa Matsuda2, Kenichiro Imai4, Sayo Ito4, Kenta Hamada5, Norimasa Fukata6, Takuya Inoue7, Hisao Tajiri9, Kenichi Yoshimura10, Hideki Ishikawa11, Shin-Ei Kudo1. 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.
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.).
RCT Entities:
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.).