UEMR vs. CEMR for Diminutive Non-pedunculated Colorectal Polyps

Colonic Polyps Clinical Trial

Official title:

Efficacy and Safety of Underwater vs. Conventional Endoscopic Mucosal Resection for the Treatment of Diminutive Non-pedunculated Colorectal Polyps：A Multicenter Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03833492
• Other study ID #: UEMR-1.0
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: November 12, 2019

Study information

• Verified date: December 2019
• Source: Ningbo No. 1 Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: November 12, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Polyps
• Polyps

Intervention

Behavioral:
• Underwater EMR
Polypectomy is performed under full water emersion without the use of submucosal injection.

Locations

Country	Name	City	State
China	Department of Gastroenterology, Haishu No.2 Hospital, Ningbo, China	Ningbo	Zhejiang
China	Department of Gastroenterology, Ninghai No.2 Hospital, Ningbo, China	Ningbo	Zhejiang
China	Ningbo first hospital	Ningbo	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Ningbo No. 1 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete resection rate	complete resection rate is defined as a complete en bloc resection of a lesion with tumor-free lateral and vertical margins.	7 days
Primary	En bloc resection rate	En bloc resection rate was defined as the entire lesion could be removed in 1 piece instead of piecemeal resection.	immediately
Secondary	Adverse event rate	Including bleeding and perforation , etc.	14 days
Secondary	Procedure time	Time to execute the program	24 hours