UEMR vs. CEMR for Diminutive Non-pedunculated Colorectal Polyps

• Sponsor: Ningbo No. 1 Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03833492
• Collaborator: (none)
• Enrollment: 130
• Locations: 3
• Arms: 2
• Actual Duration (Months): 6.4
• Patients Per Site: 43.3
• Patients Per Site Per Month: 6.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colonic Polyps	Behavioral: Underwater EMR	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 1, 2019
• Actual Primary Completion Date: Nov 1, 2019
• Actual Study Completion Date: Nov 12, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Underwater EMR; Polypectomy is performed under full water emersion without the use of submucosal injection.
No Intervention: Traditional EMR The patients who are randomized to the " Traditional EMR" arm polypectomy will be performed with selective saline injection to the layer of tissue underneath the polyp in order to create a "safety cushion" for resection.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. Adverse event rate [14 days]

   Including bleeding and perforation , etc.

2. Procedure time [24 hours]

   Time to execute the program

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Gastroenterology, Haishu No.2 Hospital, Ningbo, China	Ningbo	Zhejiang	China	315000
2	Department of Gastroenterology, Ninghai No.2 Hospital, Ningbo, China	Ningbo	Zhejiang	China	315000
3	Ningbo first hospital	Ningbo	Zhejiang	China	315010

Sponsors and Collaborators

• Ningbo No. 1 Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ningbo No. 1 Hospital
• ClinicalTrials.gov Identifier: NCT03833492
• Other Study ID Numbers: UEMR-1.0
• First Posted: Feb 7, 2019
• Last Update Posted: Dec 11, 2019
• Last Verified: Dec 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Polyps; Colonic Polyps

Study Results

No Results Posted as of Dec 11, 2019