Colorectal PolypNCT03373136
Compare Bleeding Risk Between Cold and Hot Snaring Polypectomy for Small Colorectal Polyp: a Randomized Control Trial
A study testing Polypectomy in people with Colorectal Polyp, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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 more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Colorectal Polyp
- What is being tested?
- Polypectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,270 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Feb 2018to 30 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidate has the target lesion, polyp sized 4 to 10 mm, at colonoscopy
Who cannot join
- Subjects who are less than 40 years old and has contraindication will be excluded from this study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Internal Medicine, College of Medicine, National Taiwan University
Taipei, 100
About this study
Official title: Comparison of the Bleeding Risk Between Cold and Hot Snaring Polypectomy for Small Colorectal Polyp: a Randomized Control Trial
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.
- Conditions
- Colorectal Polyp
- Being tested
- Polypectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolypectomyDevice
Polypectomy during colonoscopy is considered effective to reduce the incidence and mortality of colorectal cancer
| Study group | Role | What they receive |
|---|---|---|
| Cold snaring | Experimental | Polypectomy will be done without electrocautery Receives: Device: Polypectomy |
| Hot snaring | Active comparator | Polypectomy will be performed with electrocautery Receives: Device: Polypectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start7 Feb 2018
- Primary completion14 Aug 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Colorectal PolypStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4,270 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Han-Mo CHIU, M.D., Ph.D., Principal investigator, Department of Internal Medicine, College of Medicine, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373136
- Sponsor's protocol ID
- 201707022RINB
- Status last verified
- Aug 2020
- First submitted
- 29 Nov 2017
- Last updated
- 14 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 26545637Horiuchi 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 24125514Takeuchi 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 26634041Tseng 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.
PubMed 38775310Chang 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.
PubMed 36802753Chen 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Bleeding Risk Between Cold and Hot Snaring Polypectomy for Small Colorectal Polyp: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03373136
- Acronym / sponsor ID
- 201707022RINB
- Conditions
- Colorectal Polyp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,270 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 14 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 14 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold snaring | Experimental | Device: PolypectomyPolypectomy will be done without electrocautery |
| Hot snaring | Active comparator | Device: PolypectomyPolypectomy will be performed with electrocautery |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Candidate has the target lesion, polyp sized 4 to 10 mm, at colonoscopy
Key exclusion criteria (1 listed)
- Subjects who are less than 40 years old and has contraindication will be excluded from this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolypectomyPolypectomy during colonoscopy is considered effective to reduce the incidence and mortality of colorectal cancer | Device | Cold snaring, Hot snaring |
Primary outcome
Delayed bleeding rate
Time frame: 2 weeks
Anal bleeding with spontaneously stop; drop of Hb more than 2 gm/dl in comparison with baseline; transfusion needed; hemostasis by : colonoscopy, angiography, surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Background: PubMed 26545637Raad 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.
- Results publication: PubMed 24125514Horiuchi 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.
- Results publication: PubMed 26634041Takeuchi 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.
- Derived from this study: PubMed 38775310Tseng 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.
- Derived from this study: PubMed 36802753Chang 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.
- Derived from this study: PubMed 29980220Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Han-Mo CHIU, M.D., Ph.D. principal investigator
Department of Internal Medicine, College of Medicine, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polypectomy in people with Colorectal Polyp, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delayed bleeding rate (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03373136, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020; AzTrials last refreshed its copy on 3 Nov 2026.