NCT06996522

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
338

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress43%
Jun 2025Jul 2027

First Submitted

Initial submission to the registry

May 21, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 30, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

2.2 years

First QC Date

May 21, 2025

Last Update Submit

May 21, 2025

Conditions

Pedunculated Colorectal Polyp

Keywords

Pedunculated colorectal polypUnderwater endoscopic mucosal resectionHot snare polypectomy

Outcome Measures

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).

    2 weeks after the procedure

Secondary Outcomes (4)

  • postoperative electrocoagulation syndrome

    2 weeks after the procedure

  • en bloc resection

    immediately after the procedure

  • R0 resection

    2 weeks after the procedure

  • Delayed perforation

    2 weeks after the procedure

Study Arms (2)

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

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.

Procedure: Hot snare polypectomy

Interventions

underwater endoscopic mucosal resectionPROCEDURE

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

UEMR in treating Pedunculated colorectal polyps less than 10mm in size
Hot snare polypectomyPROCEDURE

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

HSP in treating Pedunculated colorectal polyps less than 10mm in size

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 35 and 80 years
  • Pedunculated colorectal polyps less than 10mm in size in screening, surveillance or therapeutic colonoscopy
  • Isp or 0-Ip according to Paris classification
  • Patients must sign an informed consent form prior to registration in study

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huadong hospital affiliated to Fudan university

Shanghai, Shanghai Municipality, 200040, China

Location

Study Officials

  • Zhiyu Dong, M.D.

    Huadong Hospital

    STUDY DIRECTOR

Central Study Contacts

Zhiyu Dong, M.D.

CONTACT

+86-1881787086618817870866@163.com

Danian Ji, M.D.

CONTACT

+86-18019094606arctg4@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

May 21, 2025

First Posted

May 30, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

May 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

All collected IPD

Shared Documents
STUDY PROTOCOL, SAP, ICF
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)

Locations

CN(1)