UEMR vs. CEMR for Diminutive Non-pedunculated Colorectal Polyps

Not Applicable

Completed

• Conditions: Colonic Polyps
• Interventions: Behavioral: Underwater EMR

• Registration Number: NCT03833492
• Lead Sponsor: Ningbo No. 1 Hospital

Brief Summary

This clinical trial is being conducted to compare the efficacy and safety of two standard methods of polypectomy，Conventional Endoscopic Mucosal Resection（EMR）and Underwater Endoscopic Mucosal Resection（UEMR），for small colorectal polyps.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-04
• Study First Submitted QC: 2019-02-06
• Study First Posted: 2019-02-07
• Study Start: 2019-05-01
• Primary Completion: 2019-11-01
• Study Completion: 2019-11-12
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-09
• Last Update Posted: 2019-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Patients age between 18-75 years old with non-pedunculated colonic polyps (measuring between 4 and 9mm), who willing to participate in this study.

Exclusion Criteria

1. pregnancy,
2. inflammatory bowel disease,
3. familial polyposis
4. the use of anticoagulant therapy or antiplatelet therapy
5. the absence of informed patient consent.
6. Polyps showing signs of deep submucosal invasion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Underwater EMR	Underwater EMR	The patients who are randomized to the " Underwater EMR" arm polypectomy with water will be performed under full water emersion without the use of submucosal injection.

Primary Outcome Measures

Name	Time	Method
complete resection rate	7 days	complete resection rate is defined as a complete en bloc resection of a lesion with tumor-free lateral and vertical margins.
En bloc resection rate	immediately	En bloc resection rate was defined as the entire lesion could be removed in 1 piece instead of piecemeal resection.

Secondary Outcome Measures

Name	Time	Method
Adverse event rate	14 days	Including bleeding and perforation , etc.
Procedure time	24 hours	Time to execute the program

Trial Locations

Locations (3)

Ningbo first hospital; 🇨🇳 Ningbo, Zhejiang, China

Department of Gastroenterology, Ninghai No.2 Hospital, Ningbo, China; 🇨🇳 Ningbo, Zhejiang, China

Department of Gastroenterology, Haishu No.2 Hospital, Ningbo, China; 🇨🇳 Ningbo, Zhejiang, China