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OpenTrials
Completed

NCT Number: NCT03833492

UEMR vs. CEMR for Diminutive Non-pedunculated Colorectal Polyps

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.

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Key information

Conditions

Colonic Polyps Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • pregnancy,
  • inflammatory bowel disease,
  • familial polyposis
  • the use of anticoagulant therapy or antiplatelet therapy
  • the absence of informed patient consent.
  • Polyps showing signs of deep submucosal invasion

Treatment and study plan

Underwater EMR

Behavioral

Polypectomy is performed under full water emersion without the use of submucosal injection.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Adverse event rate

    Time frame: 14 days

    Including bleeding and perforation , etc.

  2. Procedure time

    Time frame: 24 hours

    Time to execute the program

Sponsors and collaborators

Lead sponsor

Ningbo No. 1 Hospital

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 7, 2019
Registry last updated
Dec 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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