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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Fudan University
- Enrollment
- 338
- Locations
- 1
- Primary Endpoint
- Post-polypectomy Bleeding
Study Overview
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
- 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Pregnancy or breastfeeding
- •Severe comorbid disease involving the heart, lungs, liver, or kidneys.
- •Concurrent serious conditions, including other active malignancies or severe infectious diseases
Arms & Interventions
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
Intervention: underwater endoscopic mucosal resection (Procedure)
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.
Intervention: Hot snare polypectomy (Procedure)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Delayed perforation(2 weeks after the procedure)
- en bloc resection(immediately after the procedure)
- R0 resection(2 weeks after the procedure)
- postoperative electrocoagulation syndrome(2 weeks after the procedure)
Investigators
Zhijun Bao
Director
Fudan University