Clinical trial NCT06937047: Efficacy and Safety of Cold Versus Hot Snare Polypectomy for Removal of 4-10 mm Pedunculated Colorectal Polyps
Official title: Efficacy and Safety of Cold Versus Hot Snare Polypectomy for Removal of 4-10 mm Pedunculated Colorectal Polyps: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Polyps
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: delayed postoperative bleeding
timeFrame: interviewed by telephone on days 2 and 14 after polypectomy
Secondary outcomes:
measure: immediate postpolypectomy bleeding
timeFrame: during the polypectomy
measure: procedure time
timeFrame: during the polypectomy
measure: en bloc resection
timeFrame: during the polypectomy
measure: complete histologic resection
timeFrame: during the polypectomy
measure: use of haemostatic clips
timeFrame: during the polypectomy
measure: perforation rate
timeFrame: during the polypectomy, and interviewed by telephone on days 2 and 14 after polypectomy
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.