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

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

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.

Keywords: Cold snaring polypectomy; Delayed bleeding; Small colorectal polyp.

Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the Institutional Review Board of the National Taiwan University Hospital (NTUH-REC No. 201707022RINB). Written and oral informed consent is obtained from all participants before enrollment in the study.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study workflow. Patients will be enrolled and will sign the inform consent in the outpatient department. The colonoscopy will be performed in the endoscopy unit. Patients who have colorectal polyps sized 4–10 mm will be randomized into either cold or hot snaring polypectomy regardless of whether large colorectal polyps are present. Small-sized polyps will be removed by hot or cold snaring polypectomy, depending on the the patient’s allocation to the cold or hot snaring group, and large-sized polyps (> 10 mm) will receive hot snaring polypectomy, EMR, or ESD according to the colonoscopist’s decision
Fig. 2
Fig. 2
Target lesions are colorectal neoplasms 4–10 mm in size and with flat or sessile morphology. The primary outcome measurement is the risk of delayed bleeding
Fig. 3
Fig. 3
Schedule of enrollment, interventions, and assessments as per Standard Protocol Items: Recommendations for Interventional trials (SPIRIT)

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