Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Eight-year Medical Doctor Program, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
BMJ Open. 2023 May 22;13(5):e070321. doi: 10.1136/bmjopen-2022-070321.
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.
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 and cost.
The study has been approved by the institutional review board of the Peking Union Medical College Hospital (No. K2203). All participants in the trial will provide written informed consent. The results of this trial will be published in an open-access way.
NCT05545787.
冷切除术具有操作简单、耗时短、并发症少等优点。指南推荐冷圈套息肉切除术（CSP）用于切除大小≤5mm 的小息肉和大小为 6-9mm 的无蒂息肉。然而，对于大小≥10mm 的无蒂息肉，冷切除的证据较少。设计冷圈套内镜黏膜切除术（CS-EMR）结合 CSP 和黏膜下注射，旨在提高完全切除率并减少不良事件。我们假设 CS-EMR 在切除 10-19mm 无蒂结直肠息肉方面不劣于传统的热圈套内镜黏膜切除术（HS-EMR）。
这是一项前瞻性、随机、开放标签、非劣效性、单中心试验。计划接受结肠镜检查并符合条件的息肉患者将被随机分配接受 CS-EMR 或 HS-EMR 治疗。主要终点是完全切除。考虑到 HS-EMR 切除 10-19mm 结直肠息肉的完全切除率至少为 92%，非劣效性边界为-10%，共纳入 232 个息肉（单侧α，2.5%；β，20%）。分析旨在评估首先是非劣效性（组间差异的下限 95%CI 大于-10%），然后是如果达到非劣效性则评估优越性（下限 95%CI>0%）。次要终点包括整块切除、不良事件发生、内镜夹使用、切除时间和成本。
该研究已获得北京协和医学院医院机构审查委员会的批准（编号：K2203）。试验的所有参与者都将提供书面知情同意书。该试验的结果将以开放获取的方式发布。
NCT05545787。
