Cyanoacrylate to Stop Bleeding After EMR for Large Polyps

Colorectal Polyp Clinical Trial

Official title:

Efficacy of Cyanoacrylate in the Prevention of Delayed Bleeding After Endoscopic Mucosal Resection of Large Colorectal Polyps.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04308824
• Other study ID #: 683503
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2019
• Est. completion date: April 2, 2022

Study information

• Verified date: March 2020
• Source: Societa Italiana di Chirurgia ColoRettale
• Contact: Donato Altomare, Prof
• Phone: 3397593066
• Email: donatofrancesco.altomare[@]uniba.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: April 2, 2022
• Est. primary completion date: March 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Polyp
• Polyps

Intervention

Other:
• clipping
a single clip will be placed in every case of polypectomy for large colorectal polyps
• nebulization of glue
After clipping, a cyanoacrilate glue will be nebulized using a spray catheter

Locations

Country	Name	City	State
Italy	Dept of Emergency and Organ transplantation - University of Bari	Bari

Sponsors (1)

Lead Sponsor	Collaborator
Societa Italiana di Chirurgia ColoRettale

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early bleeding	Bleeding is defined as early if occurrs within 48h after the procedure	24 hours
Primary	Delayed bleeding	Bleeding is defined as delayed if occurrs more than 48 hours after the procedure	2-7 days