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

NCT ID: NCT06937047

Last Updated: 2025-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-06

Study Completion Date

2027-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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cold snare polypectomy group

Group Type EXPERIMENTAL

cold snare polypectomy

Intervention Type PROCEDURE

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

hot snare polypectomy group

Group Type ACTIVE_COMPARATOR

hot snare polypectomy

Intervention Type PROCEDURE

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

Interventions

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cold snare polypectomy

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

Intervention Type PROCEDURE

hot snare polypectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. 18-80 years old, male and female
2. Proposed colonoscopy and colonoscopy detection of at least one 4-10 mm pedunculated colorectal polyp

Exclusion Criteria

1. Contraindication to colonoscopy or polypectomy
2. Use of antiplatelet or anticoagulant drugs within 1 week before polypectomy
3. 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
4. Comorbidity with inflammatory bowel disease, colonic polyposis, or active gastrointestinal bleeding
5. Inadequate bowel preparation
6. Pregnant or lactating women
7. Failure to sign the informed consent form
8. Patients deemed ineligible by investigators to enrol in the trial
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status

Countries

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China

Central Contacts

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Yanqing Li

Role: CONTACT

+8653182169508

Facility Contacts

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Yueyue Li

Role: primary

+8618560089751

References

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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.

Reference Type BACKGROUND
PMID: 34727817 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32623550 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32112197 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38670139 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38775310 (View on PubMed)

Other Identifiers

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202504

Identifier Type: -

Identifier Source: org_study_id

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