Cyanoacrylate to Stop Bleeding After EMR for Large Polyps

NCT04308824 | Unknown

• 1 other identifier: 683503
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Early bleeding

  Bleeding is defined as early if occurrs within 48h after the procedure

  24 hours

• Delayed bleeding

  Bleeding is defined as delayed if occurrs more than 48 hours after the procedure

  2-7 days

Study Arms (2)

Clipping

ACTIVE COMPARATOR

Prophylactic endoscopic clip will be placed after polypectomy

Other: clipping

Cyanoacrilate

EXPERIMENTAL

A solution of Cyanoacrilate will be nebulized after the placement of prophylactic clip

Other: nebulization of glue

Interventions

clipping OTHER

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

Clipping

nebulization of glue OTHER

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

Cyanoacrilate

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• peduncolated or flat polyps \> 2cm of the colon
• anticoagulant therapy interrupted 5 days before the procedure

You may not qualify if:

• Coagulation disorders
• pregnancy
• malignant appearing polyps

Sponsors & Collaborators

• Societa Italiana di Chirurgia ColoRettale: lead

Study Sites (1)

Dept of Emergency and Organ transplantation - University of Bari

Bari, 70124, Italy

RECRUITING

Study Officials

• Gennaro Martines, MD

  DETO

  STUDY CHAIR

Central Study Contacts

Donato Altomare, Prof

CONTACT

3397593066; donatofrancesco.altomare@uniba.it

Arcangelo Picciariello, MD

CONTACT

+393492185104; arcangelopicciariello@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 16, 2020
• Study Start: February 2, 2019
• Primary Completion: March 2, 2022
• Study Completion: April 2, 2022
• Last Updated: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)