作者
Takahisa Matsuda,Takahiro Fujii,Yasushi Sano,Shin‐ei Kudo,Yasushi Oda,Kinichi Hotta,Tadakazu Shimoda,Yutaka Saito,Nozomu Kobayashi,Masau Sekiguchi,Kazuo Konishi,Hiroaki Ikematsu,Hiroyasu Iishi,Yoji Takeuchi,Masahiro Igarashi,Kiyonori Kobayashi,Miwa Sada,Yuichiro Yamaguchi,Kiwamu Hasuda,Tomoaki Shinohara,Hideki Ishikawa,Yoshitaka Murakami,Hirokazu Taniguchi,Takahiro Fujimori,Yoichi Ajioka,Shigeaki Yoshida
摘要
Objective To assess whether follow-up colonoscopy after polypectomy at 3 years only, or at 1 and 3 years would effectively detect advanced neoplasia (AN), including nonpolypoid colorectal neoplasms (NP-CRNs). Design A prospective multicentre randomised controlled trial was conducted in 11 Japanese institutions. The enrolled participants underwent a two-round baseline colonoscopy (interval: 1 year) to remove all neoplastic lesions. Subsequently, they were randomly assigned to undergo follow-up colonoscopy at 1 and 3 years (2-examination group) or at 3 years only (1-examination group). The incidence of AN, defined as lesions with low-grade dysplasia ≥10 mm, high-grade dysplasia or invasive cancer, at follow-up colonoscopy was evaluated. Results A total of 3926 patients were enrolled in this study. The mean age was 57.3 (range: 40–69) years, and 2440 (62%) were male. Of these, 2166 patients were assigned to two groups (2-examination: 1087, 1-examination: 1079). Overall, we detected 29 AN in 28 patients at follow-up colonoscopy in both groups. On per-protocol analysis (701 in 2-examination vs 763 in 1-examination group), the incidence of AN was similar between the two groups (1.7% vs 2.1%, p=0.599). The results of the non-inferiority test were significant (p=0.017 in per-protocol, p=0.001 in intention-to-treat analysis). NP-CRNs composed of dominantly of the detected AN (62%, 18/29), and most of them were classified into laterally spreading tumour non-granular type (83%, 15/18). Conclusion After a two-round baseline colonoscopy, follow-up colonoscopy at 3 years detected AN, including NP-CRNs, as effectively as follow-up colonoscopies performed after 1 and 3 years.