ClinicalTrials.gg
Not yet recruitingNCT06937047Updated Apr 29, 2025

Efficacy and Safety of Cold Versus Hot Snare Polypectomy for Removal of 4-10 mm Pedunculated Colorectal Polyps

An interventional study of cold snare polypectomy and hot snare polypectomy in Colorectal Polyps, sponsored by Shandong University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-29.

Sponsored by Shandong University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
196
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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. The secondary outcomes included immediate postpolypectomy bleeding, procedure time, en bloc resection, complete histologic resection, use of haemostatic clips and perforation rate.

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Conditions studied

  • Colorectal Polyps

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03

In context

Polyps

312 studies on the registry are indexed under Polyps; 60 are open to participants now.

This study's planned enrollment of 196 is above the median of 150 across 204 interventional studies indexed under Polyps.

Browse Polyps studies →

Lead sponsor

Shandong University is the lead sponsor of 292 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 18-80 years old, male and female
  2. Proposed colonoscopy and colonoscopy detection of at least one 4-10 mm pedunculated colorectal polyp

Exclusion criteria

Exclusion Criteria:

  1. to colonoscopy or polypectomy
  2. Use of antiplatelet or anticoagulant drugs within 1 week before polypectomy
  3. 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
  4. Comorbidity with inflammatory bowel disease, colonic polyposis, or active gastrointestinal bleeding
  5. Inadequate bowel preparation
  6. Pregnant or lactating women
  7. Failure to sign the form
  8. Patients deemed ineligible by investigators to enrol in the trial
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
196 participants (estimated)

Study arms

  • Experimental
    cold snare polypectomy group

    Procedure: cold snare polypectomy

  • Active comparator
    hot snare polypectomy group

    Procedure: hot snare polypectomy

Interventions

  • Procedurecold snare polypectomy

    Cold snare polypectomy was conducted for the removal of 4-10 mm pedunculated colorectal polyps.

  • Procedurehot snare polypectomy

    Hot snare polypectomy was conducted for the removal of 4-10 mm pedunculated colorectal polyps.

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What researchers measure

Primary outcomes

  1. delayed postoperative bleeding

    bleeding that developed within 2 weeks after the patient left the endoscopy unit

    Time frame: interviewed by telephone on days 2 and 14 after polypectomy

Secondary outcomes

  1. immediate postpolypectomy bleeding

    Blood spray or persistent oozing for more than 60 seconds requiring endoscopic intervention

    Time frame: during the polypectomy

  2. procedure time

    The duration from the appearance of the snare on the monitor to the time when the endoscope was withdrawn from the lesion

    Time frame: during the polypectomy

  3. en bloc resection

    Removal of a polyp with a single cut and was assessed by the colonoscopist

    Time frame: during the polypectomy

  4. complete histologic resection

    Clear resection margins, no polyp involvement

    Time frame: during the polypectomy

  5. use of haemostatic clips

    Time frame: during the polypectomy

  6. perforation rate

    Proportion of patients with intraoperative or postoperative perforation

    Time frame: during the polypectomy, and interviewed by telephone on days 2 and 14 after polypectomy

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Study locations

1 site
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References and documents

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 34727817 ↗
  • Arimoto 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 32623550 ↗
  • Arimoto 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 32112197 ↗
  • Ferlitsch 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 38670139 ↗
  • 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. PubMed 38775310 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2025; primary completion for Jan 2027, 19 months later.

Of 68 non-industry interventional studies with no phase under Polyps, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 19 months is below that.

Counting every sponsor, half of 79 studies reached it within 23 months; a quarter within 12 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 17, 2025
First posted
Apr 20, 2025
StartEst.
May 6, 2025
Primary completionEst.
Jan 1, 2027
CompletionEst.
Feb 28, 2027
Last update
Apr 29, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06937047
Responsible party
Yanqing Li (Clinical Professor, Shandong University) — Principal investigator
First posted
Apr 20, 2025
Start date
May 6, 2025 (estimated)
Primary completion
Jan 1, 2027 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
Apr 29, 2025

Study contacts

Yanqing Li
Contact
liyanqing@sdu.edu.cn
+8653182169508

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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