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10-20 mm Pedunculated Colorectal PolypNCT07114380

Investigation of Cold Snare Polypectomy for Removing 10-20 mm 0-Ip Colorectal Polyp

A study testing Cold snare polypectomy in people with 10-20 mm Pedunculated Colorectal Polyp, run by National Taiwan University Hospital at 5 sites in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a multicenter, single-arm feasibility study conducted across multiple hospitals in Taiwan. The goal of this trial is to evaluate whether cold snare polypectomy is a feasible and safe method for removing 10-20 mm pedunculated colorectal polyps. The main questions it aims to answer are: 1. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
10-20 mm Pedunculated Colorectal Polyp
What is being tested?
Cold snare polypectomy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
5 sitesTaiwan
Study dates
25 Aug 2025to Apr 2028
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 20 years
  • Undergoing colonoscopy for any clinical indication
  • Found to have a 10-20 mm pedunculated colorectal polyp suitable for cold snare polypectomy

Who cannot join

  • Age < 20 years
  • Medical contraindications to colonoscopy or polypectomy (e.g., recent myocardial infarction, stroke, severe unstable cardiovascular disease, acute peritonitis, fulminant colitis, perforation, or toxic megacolon)
  • Inadequate bowel preparation preventing complete colonoscopy or safe polypectomy

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Hsin-Yun Wu, MD contact

+886978232595

kimwu010063@gmail.com

Li-Chun Chang, MD, PhD contact

+886972651258

lichunchang@ntu.edu.tw

5 sites in 1 country

Taiwan5 sites, 5 recruiting
  • National Taiwan University Hospital Hsin-Chu Branch

    Hsinchu

    Hsuan-Ho Lin, +886972654359, to-start@hotmail.com

    Recruiting
  • National Taiwan University Hospital, Jinshan Branch

    New Taipei City, 20844

    Hsin-Yun Wu, +886972655958, kimwu010063@gmail.com

    Recruiting
  • National Taiwan University Cancer Center

    Taipei

    Hao-Che Chang, +886972653109, werdnaryu@livemail.tw

    Recruiting
  • National Taiwan University Hospital, Bei-Hu Branch

    Taipei

    Sheng-Jie Chang, +886972653951, b101097070@tmu.edu.tw

    Recruiting
  • National Taiwan University Hospital

    Taipei

    Li-Chun Chang, +886972651258, lichunchang@ntu.edu.tw

    Recruiting

Other trials in Taiwan

About this study

Official title: Investigation of Cold Snare Polypectomy for Removing 10-20 mm 0-Ip Colorectal Polyp: One Feasibility and Safety Study

This is a multicenter, single-arm feasibility study conducted across multiple hospitals in Taiwan. The goal of this trial is to evaluate whether cold snare polypectomy is a feasible and safe method for removing 10-20 mm pedunculated colorectal polyps.

The main questions it aims to answer are:

  1. Can cold snare polypectomy achieve complete removal of 10-20 mm pedunculated polyps?
  2. What are the rates and types of complications associated with this technique?

Participants will:

  1. Undergo colonoscopy as clinically indicated
  2. Have 10-20 mm pedunculated polyps removed using cold snare polypectomy if eligible
  3. Be monitored for post-procedure outcomes, including pathology results and any complications
Read the detailed description

This is a prospective, multicenter, single-arm clinical trial designed to evaluate the feasibility and safety of cold snare polypectomy (CSP) for the removal of 10-20 mm pedunculated (0-Ip) colorectal polyps. While CSP is widely recommended for polyps <10 mm due to its favorable safety profile and comparable efficacy to hot snare polypectomy (HSP), its application for larger pedunculated polyps remains insufficiently studied, particularly given concerns regarding bleeding risk.

The study will enroll 120 adult participants undergoing colonoscopy at one of five hospitals in Taiwan. Participants found to have 10-20 mm 0-Ip polyps that are deemed amenable to CSP will undergo cold snare resection by experienced endoscopists. Standard pre- and post-procedure care will be followed. Polyp characteristics, resection outcomes, and complications (e.g., immediate or delayed bleeding, perforation, emergency visits) will be recorded.

Primary endpoints include technical success (complete removal as assessed by endoscopy and pathology) and safety (rate of adverse events such as bleeding or perforation). Clinical and procedural data will be collected prospectively, and statistical analysis will be conducted to identify predictors of CSP failure using univariate and multivariate models.

This study aims to fill a critical knowledge gap in the literature regarding the appropriateness of CSP for larger pedunculated lesions and inform future guideline recommendations.

Being tested
Cold snare polypectomy
Keywords
cold snare polypectomy, pedunculated polyp, efficacy, safety

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cold snare polypectomyDevice

    Unlike traditional hot snare polypectomy or endoscopic mucosal resection, which use electrocautery to resect larger or pedunculated polyps, cold snare polypectomy uses mechanical transection alone without cautery. The procedure is performed using a dedicated cold snare by experienced endoscopists.

Study groups in NCT07114380
Study groupRoleWhat they receive
Cold snare polypectomyExperimentalParticipants in this single-arm study will undergo cold snare polypectomy (CSP) for removal of 10-20 mm pedunculated colorectal polyps identified during clinically indicated colonoscopy. CSP will be performed using standard cold snares without electrocautery. The procedure will be conducted by experienced endoscopists, and all peri-procedural care will follow routine clinical protocols. Outcomes will include complete resection rate, procedure time, and occurrence of adverse events such as immediate or delayed bleeding, perforation, and emergency visits.
Receives: Device: Cold snare polypectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cold snare polypectomy successful resection rate

    The investigators will record whether each polyp is removed by cold snare polypectomy with or without resistance. These will be considered successful resection cases. Polyps that cannot be removed by cold snare polypectomy and require switching to hot snare polypectomy will be considered failed resection cases.

    Measured: From the start of the colonoscopy to completion of the procedure, typically within 1 hour)

Secondary outcomes (11)
  1. Number of Polyps with Immediate Bleeding After Cold Snare Polypectomy

    Definition: Immediate bleeding would be assessed and graded during the procedure. The severity grades were listed as followed,

    1. Grade 1: Spontaneous hemostasis within 1 minute
    2. Grade 2: Continuous but decreased oozing over 1 minute
    3. Grade 3: Continuous oozing over 1 minute
    4. Grade 4: Active spurting

    Unit of Measure: Number of polyps with immediate bleeding, stratified by grade

    Measured: From the start of the colonoscopy to completion of the procedure, typically within 1 hour.

  2. Number of Participants with Delayed Bleeding After Cold Snare Polypectomy

    Definition: Any bleeding episode occurring after the patient has left the endoscopy unit and within 14 days post-polypectomy, classified as:

    Mild: Bleeding stops spontaneously without medical intervention

    Severe: Hemoglobin drop >2 g/dL from baseline, need for blood transfusion, or requirement of endoscopic, angiographic, or surgical hemostasis

    Unit of Measure: Number of participants with delayed bleeding

    Measured: From completion of colonoscopy until the date of first documented event, assessed up to 14 days post-procedure.

  3. Number of Participants with Perforation

    Definition: Any full-thickness defect of the colonic wall identified during or after the procedure.

    Unit of Measure: Number of participants with perforation

    Measured: From start of colonoscopy until the date of first documented event, assessed up to 14 days post-procedure.

  4. Number of Participants with Post-Polypectomy Emergency Department Visits

    Definition: Any unplanned emergency department visit related to post-polypectomy complications.

    Unit of Measure: Number of participants with emergency department visits

    Measured: From start of colonoscopy until the date of first documented event, assessed up to 14 days post-procedure.

  5. Polypectomy time

    Description: Time from when the snaring instrument first appears on the colonoscopy screen to when colonoscope withdrawal resumes after polypectomy.

    Unit of Measure: Seconds

    Measured: From the start of the colonoscopy to completion of the procedure, typically within 1 hour.

  6. Withdrawal Time

    Description: Total time taken to withdraw the colonoscope from cecum to anus

    Unit of Measure: Minutes

    Measured: From the start of the colonoscopy to completion of the procedure, typically within 1 hour.

  7. Number of Polyps with En Bloc Resection

    Description: Whether the polyp was removed in a single piece (en bloc).

    Unit of Measure: Number of polyps with en bloc resection

    Measured: From the start of the colonoscopy to completion of the procedure, typically within 1 hour.

  8. Number of Polyps with Complete Histologic Resection

    Description: Whether pathology confirms tumor-free margins in the resected specimen.

    Unit of Measure: Number of polyps with complete histologic resection

    Measured: From end of colonoscopy exam to pathology report, usually within 2 weeks.

  9. Number of Polyps Requiring Prophylactic Hemoclipping

    Description: Whether hemoclips were applied prophylactically after cold snare polypectomy.

    Unit of Measure: Number of polyps requiring prophylactic hemoclipping

    Measured: From the start of the colonoscopy to completion of the procedure, typically within 1 hour.

  10. Number of Polyps Requiring Submucosal Injection

    Description: Whether submucosal injection was required before or during cold snare polypectomy.

    Unit of Measure: Number of polyps requiring submucosal injection

    Measured: From the start of the colonoscopy to completion of the procedure, typically within 1 hour.

  11. Number of Polyps Successfully Retrieved

    Description: The number of resected polyps that are successfully retrieved and submitted for histologic evaluation.

    Unit of Measure: Number of polyps successfully retrieved

    Measured: From the start of the colonoscopy to completion of the procedure, typically within 1 hour.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2025
  2. Study start25 Aug 2025
  3. Primary completionMar 2028 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07114380
Sponsor's protocol ID
202505029RINA
Status last verified
Jul 2025
First submitted
20 Jul 2025
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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
  • 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
  • Kaltenbach T, Anderson JC, Burke CA, Dominitz JA, Gupta S, Lieberman D, Robertson DJ, Shaukat A, Syngal S, Rex DK. Endoscopic Removal of Colorectal Lesions-Recommendations by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2020 Mar;158(4):1095-1129. doi: 10.1053/j.gastro.2019.12.018. Epub 2020 Feb 11. No abstract available.

    PubMed 32122632
  • Copland AP, Kahi CJ, Ko CW, Ginsberg GG. AGA Clinical Practice Update on Appropriate and Tailored Polypectomy: Expert Review. Clin Gastroenterol Hepatol. 2024 Mar;22(3):470-479.e5. doi: 10.1016/j.cgh.2023.10.012. Epub 2023 Nov 28.

    PubMed 38032585
  • Qu J, Jian H, Li L, Zhang Y, Feng B, Li Z, Zuo X. Effectiveness and safety of cold versus hot snare polypectomy: A meta-analysis. J Gastroenterol Hepatol. 2019 Jan;34(1):49-58. doi: 10.1111/jgh.14464. Epub 2018 Sep 26.

    PubMed 30176072
  • 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.

    PubMed 36802753

Questions about this trial

What is this clinical trial studying?

A study testing Cold snare polypectomy in people with 10-20 mm Pedunculated Colorectal Polyp, run by National Taiwan University Hospital at 5 sites 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

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 Hsin-Yun Wu, MD (+886978232595, kimwu010063@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cold snare polypectomy successful resection rate (time frame: From the start of the colonoscopy to completion of the procedure, typically within 1 hour)). 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 NCT07114380, 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 19 Sep 2025.

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