Pedunculated Colorectal PolypsNCT06097650
Cold Snare Polypectomy Versus Hot Snare Polypectomy for Resection of Small Pedunculated Polyps
A study testing cold snare polypectomy and hot snare polypectomy in people with Pedunculated Colorectal Polyps and Haemorrhage, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pedunculated Colorectal Polyps, Haemorrhage
- What is being tested?
- cold snare polypectomy and hot snare polypectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2023to 15 Jun 2025
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315000
About this study
Official title: 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.
- Conditions
- Pedunculated Colorectal Polyps, Haemorrhage
- Being tested
- cold snare polypectomy, hot snare polypectomy
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold snare polypectomyOther
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
hot snare polypectomyOther
According to current clinical guidelines, hot snare polypectomy is the recommended standard technique for the resection of pedunculated colorectal polyps.
| Study group | Role | What they receive |
|---|---|---|
| cold snare polypectomy | Experimental | cold snare polypectomy for resection of small pedunculated colorectal polyps Receives: Other: cold snare polypectomy |
| hot snare polypectomy | Active comparator | hot snare polypectomy for resection of small pedunculated colorectal polyps Receives: Other: hot snare polypectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
delayed hemorrhage
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
Measured: 2 days, 2 weeks and 4 weeks
Secondary outcomes (1)
Prevalence of immediate bleeding
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
Measured: 1 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start18 Oct 2023
- Primary completion15 Jun 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pedunculated 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ninghai Second Hospital, The People's Hospital of Yuyao City, The Third People's Hospital Health Care Group of Cixi
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097650
- Sponsor's protocol ID
- 2023-140A-YJ01
- Status last verified
- Jul 2025
- First submitted
- 18 Oct 2023
- Last updated
- 24 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Snare Polypectomy Versus Hot Snare Polypectomy for the Resection of Small Pedunculated Colorectal Polyps: a Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06097650
- Acronym / sponsor ID
- 2023-140A-YJ01
- Conditions
- Pedunculated Colorectal Polyps, Haemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Collaborators
- Ninghai Second Hospital, The People's Hospital of Yuyao City, The Third People's Hospital Health Care Group of Cixi
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 24 Oct 2023 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cold snare polypectomy | Experimental | Other: cold snare polypectomycold snare polypectomy for resection of small pedunculated colorectal polyps |
| hot snare polypectomy | Active comparator | Other: hot snare polypectomyhot snare polypectomy for resection of small pedunculated colorectal polyps |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
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 polypectomyHistological analyses suggest that cold snare polypectomy causes less damage to blood vessels in the submucosal layers, which results in a reduced incidence of hemorrhage | Other | cold snare polypectomy |
| hot snare polypectomyAccording to current clinical guidelines, hot snare polypectomy is the recommended standard technique for the resection of pedunculated colorectal polyps. | Other | hot snare polypectomy |
Primary outcome
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
1 secondary outcome
Prevalence of immediate bleeding
Time frame: 1 Minutes
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 24 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pedunculated Colorectal Polyps and Haemorrhage, run by Ningbo No. 1 Hospital 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 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 24 Jul 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?
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 hemorrhage (time frame: 2 days, 2 weeks and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2025.