Chen Yen-Nien, Chang Li-Chun, Chang Chi-Yang, Chen Peng-Jen, Chen Chi-Yi, Tseng Cheng-Hao, Chiu Han-Mo
Department of Internal Medicine, National Taiwan University Hospital, Hsin-Chu Branch, Hsin-Chu, Taiwan.
Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
Trials. 2018 Jul 6;19(1):361. doi: 10.1186/s13063-018-2743-z.
Colorectal cancer remains a considerable challenge in healthcare nowadays. Most patients' disease develops via the adenoma-carcinoma sequence; colonoscopy with polypectomy effectively reduces both mortality and incidence by removing precancerous adenomas. Previous studies showed that polypectomy without electrocautery (cold snaring polypectomy) is a safe and time-saving procedure to manage polyps < 10 mm. However, randomized controlled trials have failed to prove the superiority of cold snaring polypectomy for reducing the risk of delayed bleeding in comparison with hot snaring polypectomy, generally because of their low statistical power that was limited by sample sizes. In this study, we aim to compare the risk of delayed bleeding following cold and hot snaring polypectomy based on a large sample size.
This is a prospective multicentre randomized controlled trial to compare cold and hot snaring polypectomy for the treatment of small colorectal polyps. A total of 4258 patients with small polyps (4-10 mm) will be randomized 1:1 to each group. Colonoscopy and polypectomy will be performed by 17 experienced endoscopists at six study sites. The randomization will be performed via an online website. Pathological examination using image-enhanced endoscopy with either narrow-band imaging or chromoendoscopy will be conducted to confirm optically and histologically that complete resections have been achieved, respectively. The primary outcome measurement is the risk of delayed bleeding. The secondary outcome measurements include the number of hemoclip applications, complete eradication confirmed optically and histologically, tissue retrieval rate, procedure time, emergency unit visits, and any adverse events such as immediate bleeding or perforation.
We hypothesize that cold snaring polypectomy can reduce the risk of delayed bleeding by avoiding thermal injury. In addition, this study will also compare cold and hot snaring polypectomy in terms of the complete eradication rate and procedure time. Based on data collected, we will demonstrate that cold snaring polypectomy is a safe, effective, and economic procedure for small colorectal polyps. The results will also provide additional data on which to develop recommendations for treating small colorectal polyps.
ClinicalTrials.gov, NCT03373136 . Registered on 29 November 2017.
如今，结直肠癌仍是医疗保健领域面临的重大挑战。大多数患者的疾病是通过腺瘤-癌序列发展而来的；结肠镜下息肉切除术通过切除癌前腺瘤有效降低了死亡率和发病率。既往研究表明，无电灼息肉切除术（冷圈套息肉切除术）是一种安全且节省时间的治疗直径小于10mm息肉的方法。然而，随机对照试验未能证明与热圈套息肉切除术相比，冷圈套息肉切除术在降低延迟出血风险方面具有优越性，这通常是因为其样本量有限导致统计效能较低。在本研究中，我们旨在基于大样本量比较冷圈套和热圈套息肉切除术后延迟出血的风险。
这是一项前瞻性多中心随机对照试验，比较冷圈套和热圈套息肉切除术治疗小的结直肠息肉的效果。总共4258例小息肉（4-10mm）患者将按1:1随机分配至每组。结肠镜检查和息肉切除术将由6个研究地点的17名经验丰富的内镜医师进行。随机分组将通过在线网站进行。将使用窄带成像或色素内镜的图像增强内镜进行病理检查，分别从光学和组织学上确认是否已实现完全切除。主要结局指标是延迟出血的风险。次要结局指标包括钛夹使用数量、光学和组织学确认的完全根除情况、组织获取率、手术时间、急诊就诊情况以及任何不良事件，如即刻出血或穿孔。
我们假设冷圈套息肉切除术可通过避免热损伤来降低延迟出血的风险。此外，本研究还将比较冷圈套和热圈套息肉切除术在完全根除率和手术时间方面的差异。基于收集的数据，我们将证明冷圈套息肉切除术是一种治疗小的结直肠息肉安全、有效且经济的方法。研究结果还将为制定小的结直肠息肉治疗建议提供更多数据。
ClinicalTrials.gov，NCT03373136。于2017年11月29日注册。
