Clinical trial NCT06996522: UEMR Versus HSP in the Treatment of Pedunculated Colorectal Polyps Less Than 10mm in Size
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pedunculated Colorectal Polyp
Keywords: Pedunculated colorectal polyp
Underwater endoscopic mucosal resection
Hot snare polypectomy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 338
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-polypectomy Bleeding
timeFrame: 2 weeks after the procedure
Secondary outcomes:
measure: postoperative electrocoagulation syndrome
timeFrame: 2 weeks after the procedure
measure: en bloc resection
timeFrame: immediately after the procedure
measure: R0 resection
timeFrame: 2 weeks after the procedure
measure: Delayed perforation
timeFrame: 2 weeks after the procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huadong hospital affiliated to Fudan university
state: Shanghai
Study officials:
affiliation: Huadong Hospital
name: Zhiyu Dong, M.D.
role: STUDY_DIRECTOR
References: