Abstract
BackgroundColorectal 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.MethodsThis 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.DiscussionWe 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.Trial registrationClinicalTrials.gov, NCT03373136. Registered on 29 November 2017.
Highlights
Colorectal cancer remains a considerable challenge in healthcare nowadays
This trend primarily reflects the effects of wider Colorectal cancer (CRC) screening and removal of precancerous adenomas [4]
Study design This trial is a prospective Randomized controlled trial (RCT) comparing the risk of delayed bleeding following cold and hot snaring polypectomy for the treatment of small and diminutive colorectal polyps
Summary
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. The incidence of CRC has gradually increased worldwide, except in the United States [2], where the incidence rates have declined by about 3% per year among adults aged ≥ 50 years [3] This trend primarily reflects the effects of wider CRC screening and removal of precancerous adenomas [4]. Physicians have several ways of removing small polyps, including forceps biopsy and snare polypectomy Both forceps biopsy and snare polypectomy can be further divided into hot and cold procedures that use electrocautery or manual manipulations, respectively [11]. Previous studies disclosed that cold snaring polypectomy can save more procedural time than hot snaring polypectomy [16,17,18,19]
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