Pedunculated Colorectal PolypNCT06996522
UEMR Versus HSP in the Treatment of Pedunculated Colorectal Polyps Less Than 10mm in Size
A study testing underwater endoscopic mucosal resection and Hot snare polypectomy in people with Pedunculated Colorectal Polyp, run by Fudan University at 1 site in China.
Trial summary
A prospective, single-center, open-label, randomized controlled study to compare the effectiveness and safety of underwater endoscopic mucosal resection (UEMR) and hot snare polypectomy (HSP) in treating Pedunculated colorectal polyps less than 10mm in size. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Pedunculated Colorectal Polyp
- What is being tested?
- underwater endoscopic mucosal resection and Hot snare polypectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 31 Jul 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 35 and 80 years
- Pedunculated colorectal polyps less than 10mm in size in screening, surveillance or therapeutic colonoscopy
- 0-Isp or 0-Ip according to Paris classification
- Patients must sign an informed consent form prior to registration in study
Who cannot join
- Unsuitable for removal by UEMR or HSP
- Suspected malignancy
- History of inflammatory bowel disease or colorectal resection
- Familial adenomatous polyposis or Lynch syndrome
- Patients taking anticoagulant and antiplatelet agents before the examination
- Inadequate bowel preparation, defined as a Boston Bowel Preparation Scale score < 6
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- ASA >=3
- Pregnancy or breastfeeding
- Severe comorbid disease involving the heart, lungs, liver, or kidneys.
- Concurrent serious conditions, including other active malignancies or severe infectious diseases
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
Huadong hospital affiliated to Fudan university
Shanghai, Shanghai Municipality, 200040
Zhiyu Dong, M.D., +86-18817870866, 18817870866@163.com
About this study
Official title: Underwater Endoscopic Mucosal Resection Versus Hot Snare Polypectomy in the Treatment of Pedunculated Colorectal Polyps Less Than 10mm in Size: A Single-center, Open-label, Randomized Controlled Trial
A prospective, single-center, open-label, randomized controlled study to compare the effectiveness and safety of underwater endoscopic mucosal resection (UEMR) and hot snare polypectomy (HSP) in treating Pedunculated colorectal polyps less than 10mm in size.
Read the detailed description
- Patients are undergone screening, surveillance, or therapeutic colonoscopy at the Endoscopy department of Gastrointestinal endoscopy center of Huadong hospital affiliated to Fudan University.
- Randomize patients with pedunculated colorectal polyps less than 10mm in size into 2 interventional groups based on Random function of Statistical Package for the Social Sciences (SPSS) 20.0, including (1) Group 1: Underwater endoscopic mucosal resection (UEMR) and (2) Group 2: Hot snare polypectomy (HSP).
- Collecting variables which consist of primary and secodary outcomes.
- Conditions
- Pedunculated Colorectal Polyp
- Being tested
- underwater endoscopic mucosal resection, Hot snare polypectomy
- Keywords
- Pedunculated colorectal polyp, Underwater endoscopic mucosal resection, Hot snare polypectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
underwater endoscopic mucosal resectionProcedure or surgery
The Pedunculated colorectal polyps less than 10mm in size in this group will be treated by UEMR
Hot snare polypectomyProcedure or surgery
The Pedunculated colorectal polyps less than 10mm in size in this group will be treated by HSP
| Study group | Role | What they receive |
|---|---|---|
| UEMR in treating Pedunculated colorectal polyps less than 10mm in size | Experimental | The UEMR procedure included the following: (1) Water infusion to distend the intestinal lumen; (2) entrapment of the mucosal protrusion with a snare; and (3) resection using electrocautery Receives: Procedure: underwater endoscopic mucosal resection |
| HSP in treating Pedunculated colorectal polyps less than 10mm in size | Active comparator | The HSP procedure included the following: (1) entrapment and resection of the polyp with a snare with electrocautery. Receives: Procedure: Hot snare polypectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-polypectomy Bleeding
Presence of Clinically Significant Immediate Post-polypectomy Bleeding（CSIPB） or Clinically Significant Delayed Post-polypectomy Bleeding (CSDPB). CSIPB was defined as any bleeding not responding to water jet irrigation or STSC and therefore requiring either coagu lation forceps or mechanical clips to achieve hemostasis. CSDPB was defined as any bleeding after completion of the procedure requiring emergency room presentation, hospital isation or re-intervention (endoscopy, angiography, surgery).
Measured: 2 weeks after the procedure
Secondary outcomes (4)
postoperative electrocoagulation syndrome
Postoperative electrocoagulation syndrome （PEECS）defined as localized abdominal tenderness plus at least one of the following: (1) body temperature > 37.6 °C; (2) white-blood-cell count > 10 × 10⁹ /L; or (3) C-reactive protein > 0.5 mg/dL, after ruling out delayed postoperative perforation).
Measured: 2 weeks after the procedure
en bloc resection
Rate of en bloc resection rate
Measured: immediately after the procedure
R0 resection
Rate of R0 resection
Measured: 2 weeks after the procedure
Delayed perforation
Rate of delayed perforation
Measured: 2 weeks after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pedunculated Colorectal PolypStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijun Bao, Fudan University
- Investigators
- Zhiyu Dong, M.D., Study director, Huadong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996522
- Sponsor's protocol ID
- 2025K132
- Status last verified
- May 2025
- First submitted
- 21 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Underwater Endoscopic Mucosal Resection Versus Hot Snare Polypectomy in the Treatment of Pedunculated Colorectal Polyps Less Than 10mm in Size: A Single-center, Open-label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06996522
- Acronym / sponsor ID
- 2025K132
- Conditions
- Pedunculated Colorectal Polyp
- Keywords
- Pedunculated colorectal polyp, Underwater endoscopic mucosal resection, Hot snare polypectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 30 May 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.
A prospective, single-center, open-label, randomized controlled study to compare the effectiveness and safety of underwater endoscopic mucosal resection (UEMR) and hot snare polypectomy (HSP) in treating Pedunculated colorectal polyps less than 10mm in size.
Detailed description
- Patients are undergone screening, surveillance, or therapeutic colonoscopy at the Endoscopy department of Gastrointestinal endoscopy center of Huadong hospital affiliated to Fudan University.
- Randomize patients with pedunculated colorectal polyps less than 10mm in size into 2 interventional groups based on Random function of Statistical Package for the Social Sciences (SPSS) 20.0, including (1) Group 1: Underwater endoscopic mucosal resection (UEMR) and (2) Group 2: Hot snare polypectomy (HSP).
- Collecting variables which consist of primary and secodary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UEMR in treating Pedunculated colorectal polyps less than 10mm in size | Experimental | Procedure: underwater endoscopic mucosal resectionThe UEMR procedure included the following: (1) Water infusion to distend the intestinal lumen; (2) entrapment of the mucosal protrusion with a snare; and (3) resection using electrocautery |
| HSP in treating Pedunculated colorectal polyps less than 10mm in size | Active comparator | Procedure: Hot snare polypectomyThe HSP procedure included the following: (1) entrapment and resection of the polyp with a snare with electrocautery. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 35 and 80 years
- Pedunculated colorectal polyps less than 10mm in size in screening, surveillance or therapeutic colonoscopy
- 0-Isp or 0-Ip according to Paris classification
- Patients must sign an informed consent form prior to registration in study
Key exclusion criteria (10 listed)
- Unsuitable for removal by UEMR or HSP
- Suspected malignancy
- History of inflammatory bowel disease or colorectal resection
- Familial adenomatous polyposis or Lynch syndrome
- Patients taking anticoagulant and antiplatelet agents before the examination
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 |
|---|---|---|
| underwater endoscopic mucosal resectionThe Pedunculated colorectal polyps less than 10mm in size in this group will be treated by UEMR | Procedure or surgery | UEMR in treating Pedunculated colorectal polyps less than 10mm in size |
| Hot snare polypectomyThe Pedunculated colorectal polyps less than 10mm in size in this group will be treated by HSP | Procedure or surgery | HSP in treating Pedunculated colorectal polyps less than 10mm in size |
Primary outcome
Post-polypectomy Bleeding
Time frame: 2 weeks after the procedure
Presence of Clinically Significant Immediate Post-polypectomy Bleeding（CSIPB） or Clinically Significant Delayed Post-polypectomy Bleeding (CSDPB). CSIPB was defined as any bleeding not responding to water jet irrigation or STSC and therefore requiring either coagu lation forceps or mechanical clips to achieve hemostasis. CSDPB was defined as any bleeding after completion of the procedure requiring emergency room presentation, hospital isation or re-intervention (endoscopy, angiography, surgery).
4 secondary outcomes
postoperative electrocoagulation syndrome
Time frame: 2 weeks after the procedure
en bloc resection
Time frame: immediately after the procedure
R0 resection
Time frame: 2 weeks after the procedure
Delayed perforation
Time frame: 2 weeks after the procedure
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 30 May 2025.
- Individual participant dataSharing planned: Yes. All collected IPD
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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.
Zhiyu Dong, M.D. study director
Huadong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing underwater endoscopic mucosal resection and Hot snare polypectomy in people with Pedunculated Colorectal Polyp, run by Fudan 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 4 inclusion and 10 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 30 May 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 Zhiyu Dong, M.D. (+86-18817870866, 18817870866@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-polypectomy Bleeding (time frame: 2 weeks after the procedure). 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 30 May 2025.