- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06097650
Cold Snare Polypectomy Versus Hot Snare Polypectomy for Resection of Small Pedunculated Polyps
July 20, 2025 updated by: Ningbo No. 1 Hospital
Cold Snare Polypectomy Versus Hot Snare Polypectomy for the Resection of Small Pedunculated Colorectal Polyps: a Multicentre Randomised Controlled Trial
Endoscopic resection of pedunculated polyps mainly focuses on how to prevent bleeding, and also needs to pay attention to the convenience of resection and the integrity of resection, which means that different endoscopic resection strategies should be adopted for pedunculated polyps with different stalk sizes.
Small pedunculated polyps with heads smaller than 20mm and stalks less than or equal to 5mm are defined as having a relatively small risk of bleeding.
Preliminary studies in recent years suggest that the use of cold snare polypectomy for small pedunculated polyps may also be a safe resection strategy.
However, for small pedunculated polyps, ASGE and ESGE guidelines currently recommend hot snare polypectomy in the middle and lower pedicles (evidence level medium).
Therefore, the provision of high-quality clinical evidence related to cold resection techniques in the resection strategy of small pedunculated polyps may provide a basis for revision of guidelines.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
196
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
-
Ningbo, Zhejiang, China, 315000
- The First Affiliated Hospital of Ningbo University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 1. Patients undergoing endoscopic resection of small pedicled polyps in the First Affiliated Hospital of Ningbo University, The Third People's Hospital Health Care Group of Cixi, Ninghai Second Hospital and Renmin Hospital of Yuyao City from October 2023 to August 2026; 2. Patients who voluntarily agreed to participate in this study and signed informed consent.
Exclusion Criteria:
- 1. Persons under 18 years of age 2. Persons unwilling or unable to provide informed consent 3. Treatment or radiotherapy for malignant diseases, severe chronic heart or lung diseases, coronary or cerebrovascular events requiring hospitalization within the last 3 months 4.polyps with endoscopic features suspicious for carcinoma 5. Abdominal symptoms such as severe abdominal pain, abdominal distension, and nausea 6.Patients with inadequate intestinal preparation 7. Patients with lifelong anticoagulant therapy or severe bleeding diseases, patients who have recently taken anticoagulant drugs or antiplatelet drugs (within 1 week) 8.Pregnant or lactating
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: cold snare polypectomy
cold snare polypectomy for resection of small pedunculated colorectal polyps
|
Histological analyses suggest that cold snare polypectomy causes less damage to blood vessels in the submucosal layers, which results in a reduced incidence of hemorrhage
|
|
Active Comparator: hot snare polypectomy
hot snare polypectomy for resection of small pedunculated colorectal polyps
|
According to current clinical guidelines, hot snare polypectomy is the recommended standard technique for the resection of pedunculated colorectal polyps.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
delayed hemorrhage
Time Frame: 2 days, 2 weeks and 4 weeks
|
Any symptoms of gastrointestinal bleeding (e. g. hematochezia) occurred within 30 days after polypectomy and were classified as mild or severe according on the severity of the bleeding
|
2 days, 2 weeks and 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of immediate bleeding
Time Frame: 1 Minutes
|
Immediate bleeding was defined as an intraoperative bleeding immediately after Immediate bleeding staging: If there is no bleeding, fill in 'none'; Level 1, spontaneous hemostasis within 60 seconds; Level 2, continuous small bleeding for more than 60 seconds; Level 3, continuous bleeding for more than 60 seconds requires endoscopic treatment; Level 4, arterial spray
|
1 Minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Immediate perforation rate
Time Frame: Immediate
|
perforation
|
Immediate
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 18, 2023
Primary Completion (Actual)
June 15, 2025
Study Completion (Actual)
June 15, 2025
Study Registration Dates
First Submitted
October 18, 2023
First Submitted That Met QC Criteria
October 18, 2023
First Posted (Actual)
October 24, 2023
Study Record Updates
Last Update Posted (Actual)
July 24, 2025
Last Update Submitted That Met QC Criteria
July 20, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-140A-YJ01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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