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Cyanoacrylate to Stop Bleeding After EMR for Large Polyps

NCT04308824 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2020-03-17

No results posted yet for this study

Summary

Endoscopic resection of large non-pedunculated adenomas is most often performed using the 'lift-and-cut' endoscopic mucosal resection (EMR) technique. This endoscopic technique has a relatively low technical complexity and short-duration and is commonly considered a safe and reliable surgical option, nevertheless several adverse events can occur during or after this procedure.

One of the most frequent late complication is the post-procedural bleeding occurring up to 30 days post-polypectomy, which often requires emergency hospitalization and re-intervention.

Endoscopic hemostasis of active post procedure bleeding can be achieved using prophylactic clips.

Recently, the use on sprayable hemostatic agents have been introduced in the gastrointestinal endoscopical practice.

Cyanoacrylate is a liquid tissue adhesive that has been proved to be of some utility in the endoscopic management of gastrointestinal variceal bleeding.

In this study the investigators aim to compare the rate of postoperative bleeding between two groups of patients with large colorectal polyps. In the first group it will be performed a prophylactic clipping after the polypectomy and in the other group it will be used cyanoacrylate after clipping.

Conditions

  • Colorectal Polyp

Interventions

OTHER

clipping

a single clip will be placed in every case of polypectomy for large colorectal polyps

OTHER

nebulization of glue

After clipping, a cyanoacrilate glue will be nebulized using a spray catheter

Sponsors & Collaborators

  • Societa Italiana di Chirurgia ColoRettale

    lead NETWORK

Principal Investigators

  • Gennaro Martines, MD · DETO

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-02
Primary Completion
2022-03-02
Completion
2022-04-02

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04308824 on ClinicalTrials.gov