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CompletedNCT03373136Updated Oct 14, 2020

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

An interventional study of Polypectomy in Colorectal Polyp, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2020-10-14.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
4,270
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Colorectal Polyp

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03

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
4,270 participants (actual)

Study arms

  • Experimental
    Cold snaring

    Polypectomy will be done without electrocautery

    Device: Polypectomy

  • Active comparator
    Hot snaring

    Polypectomy will be performed with electrocautery

    Device: Polypectomy

Interventions

  • DevicePolypectomy

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

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What researchers measure

Primary outcomes

  1. Delayed bleeding rate

    Anal bleeding with spontaneously stop; drop of Hb more than 2 gm/dl in comparison with baseline; transfusion needed; hemostasis by : colonoscopy, angiography, surgery

    Time frame: 2 weeks

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Study locations

1 site
  • Department of Internal Medicine, College of Medicine, National Taiwan University
    Taipei, 100, Taiwan
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References and documents

Publications

  • 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. PubMed 26545637 ↗
  • 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. PubMed 24125514 ↗
  • 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. PubMed 26634041 ↗
  • 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. PubMed 29980220 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03373136
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Dec 14, 2017
Start date
Feb 7, 2018
Primary completion
Aug 14, 2020
Completion
Aug 30, 2020
Last update
Oct 14, 2020

Study contacts

Han-Mo CHIU, M.D., Ph.D.
principal investigator · Department of Internal Medicine, College of Medicine, National Taiwan University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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