Clip Closure of Mucosal Defects After Endoscopic Mucosal Resection.

Haemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02765022
• Other study ID #: FMSALBE
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: October 2018

Study information

• Verified date: August 2018
• Source: Fundacion Miguel Servet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: October 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Clip
• Endoscopic Resection
• Haemorrhage
• Hemorrhage
• Non-pedunculated Lesions

Intervention

Device:
• Clip closure
Complete clip closure of secondary lesions after the endoscopic mucosal resection

Procedure:
• No clip closure
Observation: no clip closure of secondary lesions after the endoscopic mucosal resection

Locations

Country	Name	City	State
Spain	Eduardo Albeniz Arbizu	Pamplona	Navarra

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Miguel Servet

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delayed hemorrhage		15 days post-EMR

External Links

•   Link