ClinicalTrials.gg
Not yet recruitingNCT06996522Updated May 30, 2025

UEMR Versus HSP in the Treatment of Pedunculated Colorectal Polyps Less Than 10mm in Size

An interventional study of underwater endoscopic mucosal resection and Hot snare polypectomy in Pedunculated Colorectal Polyp, sponsored by Fudan University. Not yet recruiting at 1 site in China. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-30.

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

Phase
Not applicable
Study type
Interventional
Enrollment
338
Allocation
Randomized
Ages
35 Years to 80 Years
Sex
All
01

Study 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 the detailed description
  1. Patients are undergone screening, surveillance, or therapeutic colonoscopy at the Endoscopy department of Gastrointestinal endoscopy center of Huadong hospital affiliated to Fudan University.
  2. 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).
  3. Collecting variables which consist of primary and secodary outcomes.
02

Conditions studied

  • Pedunculated Colorectal Polyp

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Keywords

  • Pedunculated colorectal polyp
  • Underwater endoscopic mucosal resection
  • Hot snare polypectomy
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 338 is above the median of 150 across 204 interventional studies indexed under Polyps.

Browse Polyps studies →

Lead sponsor

Fudan University is the lead sponsor of 1,315 studies on the registry; 643 are open to participants now.

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

04

Who can participate

Ages eligible
35 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

  • 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 form prior to registration in study

Exclusion criteria

Exclusion Criteria:

  • Unsuitable for removal by UEMR or HSP
  • Suspected
  • 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
  • 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
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.

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.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
338 participants (estimated)

Study arms

  • Experimental
    UEMR in treating Pedunculated colorectal polyps less than 10mm in size

    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

    Procedure: underwater endoscopic mucosal resection

  • Active comparator
    HSP in treating Pedunculated colorectal polyps less than 10mm in size

    The HSP procedure included the following: (1) entrapment and resection of the polyp with a snare with electrocautery.

    Procedure: Hot snare polypectomy

Interventions

  • Procedureunderwater endoscopic mucosal resection

    The Pedunculated colorectal polyps less than 10mm in size in this group will be treated by UEMR

  • ProcedureHot snare polypectomy

    The Pedunculated colorectal polyps less than 10mm in size in this group will be treated by HSP

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 2 weeks after the procedure

Secondary outcomes

  1. 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).

    Time frame: 2 weeks after the procedure

  2. en bloc resection

    Rate of en bloc resection rate

    Time frame: immediately after the procedure

  3. R0 resection

    Rate of R0 resection

    Time frame: 2 weeks after the procedure

  4. Delayed perforation

    Rate of delayed perforation

    Time frame: 2 weeks after the procedure

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — All collected IPD

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: 1 year after completion of this study

Access criteria: All researchers can require the original data from principal investigator of this study (Email address: 18817870866@163.com)

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06996522
Lead sponsor
Fudan University
Responsible party
Zhijun Bao (Director, Fudan University) — Principal investigator
First posted
May 30, 2025
Start date
Jun 1, 2025 (estimated)
Primary completion
Jul 31, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
May 30, 2025

Study contacts

Zhiyu Dong, M.D.
Contact
18817870866@163.com
+86-18817870866
Danian Ji, M.D.
Contact
arctg4@163.com
+86-18019094606
Zhiyu Dong, M.D.
study director · Huadong Hospital

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 May 2025. You cannot join it, but the record below documents what was studied.

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