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Clip Closure of Mucosal Defects After Endoscopic Mucosal Resection.

Primary Purpose

Endoscopic Resection, Clip, Haemorrhage

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Clip closure
No clip closure
Sponsored by
Fundacion Miguel Servet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Endoscopic Resection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eduardo Albeniz Arbizu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Clip

No clip

Arm Description

Clip closure of mucosal defects after endoscopic mucosal resection.

No clip closure of mucosal defects after endoscopic mucosal resection. Observation.

Outcomes

Primary Outcome Measures

Delayed hemorrhage

Secondary Outcome Measures

Full Information

First Posted
May 3, 2016
Last Updated
January 28, 2019
Sponsor
Fundacion Miguel Servet
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1. Study Identification

Unique Protocol Identification Number
NCT02765022
Brief Title
Clip Closure of Mucosal Defects After Endoscopic Mucosal Resection.
Official Title
Clip Closure of Mucosal Defects After Endoscopic Mucosal Resection of Large Colorectal Lesions as Prophylaxis of Delayed Haemorrhage.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion Miguel Servet

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endoscopic Resection, Clip, Haemorrhage, Non-pedunculated Lesions

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
235 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clip
Arm Type
Experimental
Arm Description
Clip closure of mucosal defects after endoscopic mucosal resection.
Arm Title
No clip
Arm Type
Active Comparator
Arm Description
No clip closure of mucosal defects after endoscopic mucosal resection. Observation.
Intervention Type
Device
Intervention Name(s)
Clip closure
Intervention Description
Complete clip closure of secondary lesions after the endoscopic mucosal resection
Intervention Type
Procedure
Intervention Name(s)
No clip closure
Intervention Description
Observation: no clip closure of secondary lesions after the endoscopic mucosal resection
Primary Outcome Measure Information:
Title
Delayed hemorrhage
Time Frame
15 days post-EMR

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Eduardo Albeniz Arbizu
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
31362007
Citation
Albeniz E, Alvarez MA, Espinos JC, Nogales O, Guarner C, Alonso P, Rodriguez-Tellez M, Herreros de Tejada A, Santiago J, Bustamante-Balen M, Rodriguez Sanchez J, Ramos-Zabala F, Valdivielso E, Martinez-Alcala F, Fraile M, Elosua A, Guerra Veloz MF, Ibanez Beroiz B, Capdevila F, Enguita-German M. Clip Closure After Resection of Large Colorectal Lesions With Substantial Risk of Bleeding. Gastroenterology. 2019 Nov;157(5):1213-1221.e4. doi: 10.1053/j.gastro.2019.07.037. Epub 2019 Jul 27.
Results Reference
derived
Links:
URL
http://navarrabiomed.es
Description
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Clip Closure of Mucosal Defects After Endoscopic Mucosal Resection.

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