NCT03373136

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 14, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 7, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2020

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

October 14, 2020

Status Verified

August 1, 2020

Enrollment Period

2.5 years

First QC Date

November 29, 2017

Last Update Submit

October 12, 2020

Conditions

Colorectal Polyp

Outcome Measures

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

    2 weeks

Study Arms (2)

Cold snaring

EXPERIMENTAL

Polypectomy will be done without electrocautery

Device: Polypectomy

Hot snaring

ACTIVE COMPARATOR

Polypectomy will be performed with electrocautery

Device: Polypectomy

Interventions

PolypectomyDEVICE

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

Cold snaringHot snaring

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Taipei, 100, Taiwan

Location

Related Publications (6)

  • 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.

    PMID: 26545637BACKGROUND

  • 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.

    PMID: 24125514RESULT

  • 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.

    PMID: 26634041RESULT

  • 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: 38775310DERIVED

  • 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.

    PMID: 36802753DERIVED

  • 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.

    PMID: 29980220DERIVED

Study Officials

  • Han-Mo CHIU, M.D., Ph.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2017

First Posted

December 14, 2017

Study Start

February 7, 2018

Primary Completion

August 14, 2020

Study Completion

August 30, 2020

Last Updated

October 14, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)