Efficacy and Safety of Cold Versus Hot Snare Polypectomy for Removal of 4-10 mm Pedunculated Colorectal Polyps

NCT06937047 | Not Yet Recruiting

• 1 other identifier: 202504
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

This was a non-inferiority randomized controlled trial designed to compare the efficacy and safety of cold versus hot snare polypectomy for the removal of 4-10 mm pedunculated colorectal polyps. The primary outcome was delayed postpolypectomy bleeding. The secondary outcomes included immediate postpolypectomy bleeding, procedure time, en bloc resection, complete histologic resection, use of haemostatic clips and perforation rate.

Conditions

Colorectal Polyps

Outcome Measures

Primary Outcomes (1)

• delayed postoperative bleeding

  bleeding that developed within 2 weeks after the patient left the endoscopy unit

  interviewed by telephone on days 2 and 14 after polypectomy

Secondary Outcomes (6)

• immediate postpolypectomy bleeding

  during the polypectomy

• procedure time

  during the polypectomy

• en bloc resection

  during the polypectomy

• complete histologic resection

  during the polypectomy

• use of haemostatic clips

  during the polypectomy

Study Arms (2)

cold snare polypectomy group

EXPERIMENTAL

Procedure: cold snare polypectomy

hot snare polypectomy group

ACTIVE COMPARATOR

Procedure: hot snare polypectomy

Interventions

cold snare polypectomy PROCEDURE

Cold snare polypectomy was conducted for the removal of 4-10 mm pedunculated colorectal polyps.

cold snare polypectomy group

hot snare polypectomy PROCEDURE

Hot snare polypectomy was conducted for the removal of 4-10 mm pedunculated colorectal polyps.

hot snare polypectomy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old, male and female
• Proposed colonoscopy and colonoscopy detection of at least one 4-10 mm pedunculated colorectal polyp

You may not qualify if:

• Contraindication to colonoscopy or polypectomy
• Use of antiplatelet or anticoagulant drugs within 1 week before polypectomy
• Alarming signs and symptoms of colorectal cancer (blood in stool, black stool, unexplained anaemia and weight loss, abdominal mass, positive rectal examination; or imaging and laboratory tests highly suspicious for colorectal cancer) or endoscopic manifestations of polyps highly suspicious for high-grade intraepithelial neoplasia or carcinoma
• Comorbidity with inflammatory bowel disease, colonic polyposis, or active gastrointestinal bleeding
• Inadequate bowel preparation
• Pregnant or lactating women
• Failure to sign the informed consent form
• Patients deemed ineligible by investigators to enrol in the trial

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Related Publications (5)

• Arimoto J, Chiba H, Tachikawa J, Yamaoka K, Yamazaki D, Higa A, Okada N, Suto T, Kawano N, Niikura T, Kuwabara H, Nakaoka M, Ida T, Morohashi T, Goto T. Evaluation of cold snare polypectomy for small pedunculated (Ip) polyps with thin stalks: a prospective clinical feasibility study. Scand J Gastroenterol. 2022 Feb;57(2):253-259. doi: 10.1080/00365521.2021.1998603. Epub 2021 Nov 2.

  PMID: 34727817 BACKGROUND

• Arimoto J, Chiba H, Ashikari K, Fukui R, Tachikawa J, Okada N, Suto T, Kawano N, Niikura T, Kuwabara H, Nakaoka M, Ida T, Goto T, Nakajima A. Management of Less Than 10-mm-Sized Pedunculated (Ip) Polyps with Thin Stalk: Hot Snare Polypectomy Versus Cold Snare Polypectomy. Dig Dis Sci. 2021 Jul;66(7):2353-2361. doi: 10.1007/s10620-020-06436-7. Epub 2020 Jul 4.

  PMID: 32623550 BACKGROUND

• Arimoto J, Chiba H, Ashikari K, Fukui R, Tachikawa J, Suto T, Kawano N, Niikura T, Kuwabara H, Nakaoka M, Ida T, Higurashi T, Goto T, Nakajima A. Safety and efficacy of cold snare polypectomy for pedunculated (Ip) polyps measuring less than 10 mm in diameter. Int J Colorectal Dis. 2020 May;35(5):859-867. doi: 10.1007/s00384-020-03547-5. Epub 2020 Feb 28.

  PMID: 32112197 BACKGROUND

• Ferlitsch M, Hassan C, Bisschops R, Bhandari P, Dinis-Ribeiro M, Risio M, Paspatis GA, Moss A, Libanio D, Lorenzo-Zuniga V, Voiosu AM, Rutter MD, Pellise M, Moons LMG, Probst A, Awadie H, Amato A, Takeuchi Y, Repici A, Rahmi G, Koecklin HU, Albeniz E, Rockenbauer LM, Waldmann E, Messmann H, Triantafyllou K, Jover R, Gralnek IM, Dekker E, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2024. Endoscopy. 2024 Jul;56(7):516-545. doi: 10.1055/a-2304-3219. Epub 2024 Apr 26.

  PMID: 38670139 BACKGROUND

• Tseng CH, Chang LC, Wu JL, Chang CY, Chen CY, Chen PJ, Shun CT, Hsu WF, Chen YN, Chen CC, Huang TY, Tu CH, Chen MJ, Chou CK, Lee CT, Chen PY, Lin JT, Wu MS, Chiu HM. Bleeding Risk of Cold Versus Hot Snare Polypectomy for Pedunculated Colorectal Polyps Measuring 10 mm or Less: Subgroup Analysis of a Large Randomized Controlled Trial. Am J Gastroenterol. 2024 Nov 1;119(11):2233-2240. doi: 10.14309/ajg.0000000000002847. Epub 2024 May 9.

  PMID: 38775310 BACKGROUND

Central Study Contacts

Yanqing Li

CONTACT

+8653182169508; liyanqing@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 20, 2025
• Study Start: May 6, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)