UEMR vs. CEMR for Diminutive Non-pedunculated Colorectal Polyps

December 9, 2019 updated by: Ningbo No. 1 Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Ningbo, Zhejiang, China, 315010
        • Ningbo First Hospital
      • Ningbo, Zhejiang, China, 315000
        • Department of Gastroenterology, Haishu No.2 Hospital, Ningbo, China
      • Ningbo, Zhejiang, China, 315000
        • Department of Gastroenterology, Ninghai No.2 Hospital, Ningbo, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse event rate
Time Frame: 14 days
Including bleeding and perforation , etc.
14 days
Procedure time
Time Frame: 24 hours
Time to execute the program
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ningbo No. 1 Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

November 12, 2019

Study Registration Dates

First Submitted

February 4, 2019

First Submitted That Met QC Criteria

February 6, 2019

First Posted (Actual)

February 7, 2019

Study Record Updates

Last Update Posted (Actual)

December 11, 2019

Last Update Submitted That Met QC Criteria

December 9, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UEMR-1.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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