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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Comparison of cold and hot snaring polypectomy for small colorectal polyps: study protocol for a randomized controlled trial

Authors: Yen-Nien Chen, Li-Chun Chang, Chi-Yang Chang, Peng-Jen Chen, Chi-Yi Chen, Cheng-Hao Tseng, Han-Mo Chiu

Published in: Trials | Issue 1/2018

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Abstract

Background

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.

Methods

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.

Discussion

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.

Trial registration

ClinicalTrials.gov, NCT03373136. Registered on 29 November 2017.
Appendix
Available only for authorised users
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Metadata
Title
Comparison of cold and hot snaring polypectomy for small colorectal polyps: study protocol for a randomized controlled trial
Authors
Yen-Nien Chen
Li-Chun Chang
Chi-Yang Chang
Peng-Jen Chen
Chi-Yi Chen
Cheng-Hao Tseng
Han-Mo Chiu
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2743-z

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