Colorectal PolypsNCT06937047
Efficacy and Safety of Cold Versus Hot Snare Polypectomy for Removal of 4-10 mm Pedunculated Colorectal Polyps
A study testing cold snare polypectomy and hot snare polypectomy in people with Colorectal Polyps, run by Shandong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Polyps
- What is being tested?
- cold snare polypectomy and hot snare polypectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2025to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years old, male and female
- Proposed colonoscopy and colonoscopy detection of at least one 4-10 mm pedunculated colorectal polyp
Who cannot join
- Contraindication to colonoscopy or polypectomy
- Use of antiplatelet or anticoagulant drugs within 1 week before polypectomy
- 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
- Comorbidity with inflammatory bowel disease, colonic polyposis, or active gastrointestinal bleeding
- Inadequate bowel preparation
- Pregnant or lactating women
- Failure to sign the informed consent form
- Patients deemed ineligible by investigators to enrol in the trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Yueyue Li, +8618560089751, lyynqj@126.com
About this study
Official title: Efficacy and Safety of Cold Versus Hot Snare Polypectomy for Removal of 4-10 mm Pedunculated Colorectal Polyps: a Randomized Controlled Trial
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.
- Conditions
- Colorectal Polyps
- Being tested
- cold snare polypectomy, hot snare polypectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold snare polypectomyProcedure or surgery
Cold snare polypectomy was conducted for the removal of 4-10 mm pedunculated colorectal polyps.
hot snare polypectomyProcedure or surgery
Hot snare polypectomy was conducted for the removal of 4-10 mm pedunculated colorectal polyps.
| Study group | Role | What they receive |
|---|---|---|
| cold snare polypectomy group | Experimental | Not described Receives: Procedure: cold snare polypectomy |
| hot snare polypectomy group | Active comparator | Not described Receives: Procedure: hot snare polypectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
delayed postoperative bleeding
bleeding that developed within 2 weeks after the patient left the endoscopy unit
Measured: interviewed by telephone on days 2 and 14 after polypectomy
Secondary outcomes (6)
immediate postpolypectomy bleeding
Blood spray or persistent oozing for more than 60 seconds requiring endoscopic intervention
Measured: during the polypectomy
procedure time
The duration from the appearance of the snare on the monitor to the time when the endoscope was withdrawn from the lesion
Measured: during the polypectomy
en bloc resection
Removal of a polyp with a single cut and was assessed by the colonoscopist
Measured: during the polypectomy
complete histologic resection
Clear resection margins, no polyp involvement
Measured: during the polypectomy
use of haemostatic clips
Measured: during the polypectomy
perforation rate
Proportion of patients with intraoperative or postoperative perforation
Measured: during the polypectomy, and interviewed by telephone on days 2 and 14 after polypectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start6 May 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Colorectal PolypsStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937047
- Sponsor's protocol ID
- 202504
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34727817Arimoto 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.
PubMed 32623550Arimoto 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.
PubMed 32112197Ferlitsch 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.
PubMed 38670139Tseng 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 38775310
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Cold Versus Hot Snare Polypectomy for Removal of 4-10 mm Pedunculated Colorectal Polyps: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06937047
- Acronym / sponsor ID
- 202504
- Conditions
- Colorectal Polyps
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 6 May 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 20 Apr 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cold snare polypectomy group | Experimental | Procedure: cold snare polypectomy |
| hot snare polypectomy group | Active comparator | Procedure: hot snare polypectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-80 years old, male and female
- Proposed colonoscopy and colonoscopy detection of at least one 4-10 mm pedunculated colorectal polyp
Key exclusion criteria (8 listed)
- Contraindication to colonoscopy or polypectomy
- Use of antiplatelet or anticoagulant drugs within 1 week before polypectomy
- 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
- Comorbidity with inflammatory bowel disease, colonic polyposis, or active gastrointestinal bleeding
- Inadequate bowel preparation
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 |
|---|---|---|
| cold snare polypectomyCold snare polypectomy was conducted for the removal of 4-10 mm pedunculated colorectal polyps. | Procedure or surgery | cold snare polypectomy group |
| hot snare polypectomyHot snare polypectomy was conducted for the removal of 4-10 mm pedunculated colorectal polyps. | Procedure or surgery | hot snare polypectomy group |
Primary outcome
delayed postoperative bleeding
Time frame: interviewed by telephone on days 2 and 14 after polypectomy
bleeding that developed within 2 weeks after the patient left the endoscopy unit
6 secondary outcomes
immediate postpolypectomy bleeding
Time frame: during the polypectomy
procedure time
Time frame: during the polypectomy
en bloc resection
Time frame: during the polypectomy
complete histologic resection
Time frame: during the polypectomy
use of haemostatic clips
Time frame: during the polypectomy
perforation rate
Time frame: during the polypectomy, and interviewed by telephone on days 2 and 14 after polypectomy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Results publication: PubMed 34727817Arimoto 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.
- Results publication: PubMed 32623550Arimoto 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.
- Results publication: PubMed 32112197Arimoto 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.
- Results publication: PubMed 38670139Ferlitsch 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.
- Results publication: 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.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cold snare polypectomy and hot snare polypectomy in people with Colorectal Polyps, run by Shandong University at 1 site in China.
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 2 inclusion and 8 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: opening soon, as of the sponsor's last update on 29 Apr 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanqing Li (+8653182169508, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
delayed postoperative bleeding (time frame: interviewed by telephone on days 2 and 14 after polypectomy). 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 NCT06937047, which also lists 5 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 29 Apr 2025.