Clip Closure of Mucosal Defects After Endoscopic Mucosal Resection.

F

Fundacion Miguel Servet

Status

Completed

Conditions

Clip
Non-pedunculated Lesions
Haemorrhage
Endoscopic Resection

Treatments

Device: Clip closure
Procedure: No clip closure

Study type

Interventional

Funder types

Other

Identifiers

NCT02765022
FMSALBE

Details and patient eligibility

About

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.

Enrollment

235 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

235 participants in 2 patient groups

Clip
Experimental group
Description:
Clip closure of mucosal defects after endoscopic mucosal resection.
Treatment:
Device: Clip closure
No clip
Active Comparator group
Description:
No clip closure of mucosal defects after endoscopic mucosal resection. Observation.
Treatment:
Procedure: No clip closure

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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