Endoscopic mucosal resection using cold snare versus hot snare in treatment for 10–19 mm non-pedunculated colorectal polyps: protocol of a non-inferiority randomised controlled study

作者：Qingwei Jiang, Xiaxiao Yan, Duan Wang, Shengyu Zhang, Yuelun Zhang, Yunlu Feng, Aiming Yang, Dong Wu · 发表于：BMJ Open · 年份：2023 · DOI：10.1136/bmjopen-2022-070321 · 被引用次数：5 · 研究领域：Gastric Cancer Management and Outcomes、Colorectal Cancer Screening and Detection、Gastrointestinal Tumor Research and Treatment

INTRODUCTION: Cold polypectomy has the advantages of simple operation, less time-consuming and fewer complications. Guidelines have recommended cold snare polypectomy (CSP) to resect small polyps sized ≤5 mm and sessile polyps sized 6-9 mm. However, evidence is scarce regarding cold resection for non-pedunculated polyps sized ≥10 mm. Cold snare endoscopic mucosal resection (CS-EMR) combining CSP and submucosal injection was designed to improve the complete resection rate and reduce adverse events. We hypothesise that CS-EMR is non-inferior to conventional hot snare endoscopic mucosal resection (HS-EMR) in the resection of 10-19 mm non-pedunculated colorectal polyps. METHODS AND ANALYSIS: This study is a prospective, randomised, open-label, non-inferiority, single-centre trial. Outpatients scheduled to undergo a colonoscopy and present eligible polyps will be randomised to receive either CS-EMR or HS-EMR. The primary endpoint is the complete resection. Considering that HS-EMR of 10-19 mm colorectal polyps will yield a complete resection rate of at least 92% and a non-inferiority margin of -10%, a total of 232 polyps will be included (one-sided α, 2.5%; β, 20%). The analyses are intended to evaluate first non-inferiority (lower limit 95% CI greater than -10% for group difference) and then superiority (lower limit 95% CI>0%) if non-inferiority is achieved. Secondary endpoints include en-bloc resection, the occurrence of adverse events, the use of endoscopic clips, resection time...