Cyanoacrylate to Stop Bleeding After EMR for Large Polyps

NCT ID: NCT04308824

Last Updated: 2020-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-02
• Study Completion Date: 2022-04-02

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.

Detailed Description

Introduction of endoscopic removal of colorectal polyps in the clinical practice has profoundly contributed to the modified epidemiology of colorectal cancer in western countries by reducing its incidence and mortality through a primary prevention. Endoscopic removal of polyps can be carried out using several techniques depending on their morphology, size, location along the colon and the expertise of the endoscopist.

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, even in experienced hands. One of the most frequent late complication is the post-procedural bleeding (PPB) occurring up to 30 days post-polypectomy, which often requires emergency hospitalization and re-intervention (by repeated endoscopy, angiography, or even major surgery). The frequency of PPB after EMR of colonic polyps is reported between 0.4 % and 7 % depending on patients' co-morbidities and medications, location and size of the polyps and endoscopic technique.

Endoscopic hemostasis of active PPB can be achieved using different techniques according to the location and characteristics of the lesion, endoscopist's preference and experience, and device availability. However, the most commonly method used is clipping with or without adrenaline injection.

Recently, the use on sprayable hemostatic agents have been introduced in the gastrointestinal endoscopical practice providing a non-traumatic and technically easy method of hemostasis which can be used also in cases of diffuse, multifocal source of bleeding due to ulcers, tumors or post-EMR or in areas difficult to access, such as the lesser curvature of the stomach, posterior wall of the duodenal bulb.

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, we will compare the short and mid-term results of the endoscopic use of N-butyl-2-cyanoacrylate associated with methacryloxysulfolane in the prevention of delayed bleeding after EMR of large colorectal polyps.

Conditions

Colorectal Polyp

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Clipping

Prophylactic endoscopic clip will be placed after polypectomy

Group Type: ACTIVE_COMPARATOR

clipping

Intervention Type: OTHER

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

Cyanoacrilate

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

Group Type: EXPERIMENTAL

nebulization of glue

Intervention Type: OTHER

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

Interventions

clipping

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

Intervention Type: OTHER

nebulization of glue

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Coagulation disorders
• pregnancy
• malignant appearing polyps

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Societa Italiana di Chirurgia ColoRettale

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gennaro Martines, MD

Role: STUDY_CHAIR

DETO

Locations

Dept of Emergency and Organ transplantation - University of Bari

Bari, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Donato Altomare, Prof

Role: CONTACT

donatofrancesco.altomare@uniba.it

3397593066

Arcangelo Picciariello, MD

Role: CONTACT

arcangelopicciariello@gmail.com

+393492185104

Facility Contacts

Donato F Altomare, Prof

Role: primary

donatofrancesco.altomare@uniba.it

Other Identifiers

683503

Identifier Type: -

Identifier Source: org_study_id