Clip Closure of Mucosal Defects After Endoscopic Mucosal Resection.

January 28, 2019 updated by: Fundacion Miguel Servet

Clip Closure of Mucosal Defects After Endoscopic Mucosal Resection of Large Colorectal Lesions as Prophylaxis of Delayed Haemorrhage.

An simple-blind, randomized study, to evaluate the efficacy and safety of complete closure with clips of mucosal defects after endoscopic mucosal resection (EMR) of large non-pedunculated colorectal lesions (≥ 2 cm) as prophylaxis of delayed bleeding.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

235

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

  • Spain
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Eduardo Albeniz Arbizu

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years and older
  • Clinical indication of endoscopic mucosal resection for large-sized (≥ 2cm) non-pedunculated colorectal lesions.
  • Medium-high risk of delayed bleeding (DB risk score ≥ 4)
  • Informed consent.

Exclusion Criteria:

  • Patients with colorectal non-pedunculated lesions without endoscopic mucosal resection indication.
  • Lesions resected by endoscopic submucosal resection.
  • Incomplete resections.
  • Resections with suspected deep submucosal invasion.
  • Mucosal defects treated with clips for known or suspected damage to the muscle layer.
  • Lesions with low risk of delayed bleeding (DB risk score ≤3).
  • Patients with any other medical, geographic or social condition, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clip
Clip closure of mucosal defects after endoscopic mucosal resection.
Device: Clip closure
Complete clip closure of secondary lesions after the endoscopic mucosal resection
Active Comparator: No clip
No clip closure of mucosal defects after endoscopic mucosal resection. Observation.
Procedure: No clip closure
Observation: no clip closure of secondary lesions after the endoscopic mucosal resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Delayed hemorrhage
Time Frame: 15 days post-EMR
15 days post-EMR

Collaborators and Investigators

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

Sponsor

Fundacion Miguel Servet

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

Helpful Links

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, 2016

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

May 3, 2016

First Submitted That Met QC Criteria

May 4, 2016

First Posted (Estimate)

May 6, 2016

Study Record Updates

Last Update Posted (Actual)

January 29, 2019

Last Update Submitted That Met QC Criteria

January 28, 2019

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMSALBE

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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