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

NCT ID: NCT06996522

Last Updated: 2025-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

338 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2027-07-31

Brief Summary

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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

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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.

Conditions

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Pedunculated Colorectal Polyp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

underwater endoscopic mucosal resection

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Hot snare polypectomy

Intervention Type PROCEDURE

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

Interventions

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underwater endoscopic mucosal resection

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

Intervention Type PROCEDURE

Hot snare polypectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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 informed consent form prior to registration in study

Exclusion Criteria

* 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
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Zhijun Bao

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhiyu Dong, M.D.

Role: STUDY_DIRECTOR

Huadong Hospital

Locations

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Huadong hospital affiliated to Fudan university

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Zhiyu Dong, M.D.

Role: CONTACT

+86-18817870866

Danian Ji, M.D.

Role: CONTACT

+86-18019094606

Facility Contacts

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Zhiyu Dong, M.D.

Role: primary

+86-18817870866

Other Identifiers

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2025K132

Identifier Type: -

Identifier Source: org_study_id

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