Compare Bleeding Risk Between Cold and Hot Snaring Polypectomy for Small Colorectal Polyp: a Randomized Control Trial

NCT ID: NCT03373136

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-07
• Study Completion Date: 2020-08-30

Brief Summary

In this randomized control trial the investigators aim to compare the bleeding complication between cold snaring and hot snaring polypectomy with a large sample size.

Detailed Description

The investigators will enroll subjects who receive screening or surveillance colonoscopy with small colorectal polyp, 4 to10 mm in size, from multiple centers in Taiwan. Subjects who are less than 40 years old and has contraindication will be excluded from this study. All the candidates for enrollment will sign the inform consent at the outpatient clinic. Once the candidate has the target lesion, polyp sized 4 to 10 mm, at colonoscopy will be randomized into either cold snaring or hot snaring polypectomy group. In the group with cold snaring, polypectomy will be done without electrocautery. In the hot snaring group, the polypectomy will be performed with electrocautery. The bowel preparation and colonoscopy insertion are the same in both groups as conventional colonoscopy method. The colonoscopy will be performed by experienced endoscopies who performed more than 100 polypectomies per year.

Conditions

Colorectal Polyp

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cold snaring

Polypectomy will be done without electrocautery

Group Type: EXPERIMENTAL

Polypectomy

Intervention Type: DEVICE

Polypectomy during colonoscopy is considered effective to reduce the incidence and mortality of colorectal cancer

Hot snaring

Polypectomy will be performed with electrocautery

Group Type: ACTIVE_COMPARATOR

Polypectomy

Intervention Type: DEVICE

Polypectomy during colonoscopy is considered effective to reduce the incidence and mortality of colorectal cancer

Interventions

Polypectomy

Polypectomy during colonoscopy is considered effective to reduce the incidence and mortality of colorectal cancer

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Candidate has the target lesion, polyp sized 4 to 10 mm, at colonoscopy

Exclusion Criteria

• Subjects who are less than 40 years old and has contraindication will be excluded from this study

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Han-Mo CHIU, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, College of Medicine, National Taiwan University

Locations

Department of Internal Medicine, College of Medicine, National Taiwan University

Taipei, , Taiwan

Countries

Taiwan

References

Raad D, Tripathi P, Cooper G, Falck-Ytter Y. Role of the cold biopsy technique in diminutive and small colonic polyp removal: a systematic review and meta-analysis. Gastrointest Endosc. 2016 Mar;83(3):508-15. doi: 10.1016/j.gie.2015.10.038. Epub 2015 Nov 9.

Reference Type: BACKGROUND

PMID: 26545637 (View on PubMed)

Horiuchi A, Nakayama Y, Kajiyama M, Tanaka N, Sano K, Graham DY. Removal of small colorectal polyps in anticoagulated patients: a prospective randomized comparison of cold snare and conventional polypectomy. Gastrointest Endosc. 2014 Mar;79(3):417-23. doi: 10.1016/j.gie.2013.08.040. Epub 2013 Oct 11.

Reference Type: RESULT

PMID: 24125514 (View on PubMed)

Takeuchi Y, Yamashina T, Matsuura N, Ito T, Fujii M, Nagai K, Matsui F, Akasaka T, Hanaoka N, Higashino K, Iishi H, Ishihara R, Thorlacius H, Uedo N. Feasibility of cold snare polypectomy in Japan: A pilot study. World J Gastrointest Endosc. 2015 Nov 25;7(17):1250-6. doi: 10.4253/wjge.v7.i17.1250.

Reference Type: RESULT

PMID: 26634041 (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: DERIVED

PMID: 38775310 (View on PubMed)

Chang LC, Chang CY, Chen CY, Tseng CH, Chen PJ, Shun CT, Hsu WF, Chen YN, Chen CC, Huang TY, Tu CH, Chen MJ, Chou CK, Lee CT, Chen PY, Wu MS, Chiu HM. Cold Versus Hot Snare Polypectomy for Small Colorectal Polyps : A Pragmatic Randomized Controlled Trial. Ann Intern Med. 2023 Mar;176(3):311-319. doi: 10.7326/M22-2189. Epub 2023 Feb 21.

Reference Type: DERIVED

PMID: 36802753 (View on PubMed)

Chen YN, Chang LC, Chang CY, Chen PJ, Chen CY, Tseng CH, Chiu HM. Comparison of cold and hot snaring polypectomy for small colorectal polyps: study protocol for a randomized controlled trial. Trials. 2018 Jul 6;19(1):361. doi: 10.1186/s13063-018-2743-z.

Reference Type: DERIVED

PMID: 29980220 (View on PubMed)

Other Identifiers

201707022RINB

Identifier Type: -

Identifier Source: org_study_id