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Cyanoacrylate to Stop Bleeding After EMR for Large Polyps

Primary Purpose

Colorectal Polyp

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
clipping
nebulization of glue
Sponsored by
Societa Italiana di Chirurgia ColoRettale
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Polyp

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept of Emergency and Organ transplantation - University of BariRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Clipping

Cyanoacrilate

Arm Description

Prophylactic endoscopic clip will be placed after polypectomy

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

Outcomes

Primary Outcome Measures

Early bleeding
Bleeding is defined as early if occurrs within 48h after the procedure
Delayed bleeding
Bleeding is defined as delayed if occurrs more than 48 hours after the procedure

Secondary Outcome Measures

Full Information

First Posted
March 11, 2020
Last Updated
March 13, 2020
Sponsor
Societa Italiana di Chirurgia ColoRettale
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1. Study Identification

Unique Protocol Identification Number
NCT04308824
Brief Title
Cyanoacrylate to Stop Bleeding After EMR for Large Polyps
Official Title
Efficacy of Cyanoacrylate in the Prevention of Delayed Bleeding After Endoscopic Mucosal Resection of Large Colorectal Polyps.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 2, 2019 (Actual)
Primary Completion Date
March 2, 2022 (Anticipated)
Study Completion Date
April 2, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Societa Italiana di Chirurgia ColoRettale

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Polyp

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clipping
Arm Type
Active Comparator
Arm Description
Prophylactic endoscopic clip will be placed after polypectomy
Arm Title
Cyanoacrilate
Arm Type
Experimental
Arm Description
A solution of Cyanoacrilate will be nebulized after the placement of prophylactic clip
Intervention Type
Other
Intervention Name(s)
clipping
Intervention Description
a single clip will be placed in every case of polypectomy for large colorectal polyps
Intervention Type
Other
Intervention Name(s)
nebulization of glue
Intervention Description
After clipping, a cyanoacrilate glue will be nebulized using a spray catheter
Primary Outcome Measure Information:
Title
Early bleeding
Description
Bleeding is defined as early if occurrs within 48h after the procedure
Time Frame
24 hours
Title
Delayed bleeding
Description
Bleeding is defined as delayed if occurrs more than 48 hours after the procedure
Time Frame
2-7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donato Altomare, Prof
Phone
3397593066
Email
donatofrancesco.altomare@uniba.it
First Name & Middle Initial & Last Name or Official Title & Degree
Arcangelo Picciariello, MD
Phone
+393492185104
Email
arcangelopicciariello@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gennaro Martines, MD
Organizational Affiliation
DETO
Official's Role
Study Chair
Facility Information:
Facility Name
Dept of Emergency and Organ transplantation - University of Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donato F Altomare, Prof
Email
donatofrancesco.altomare@uniba.it
First Name & Middle Initial & Last Name & Degree
Donato Altomare, MD
First Name & Middle Initial & Last Name & Degree
Arcangelo Picciariello, MD
First Name & Middle Initial & Last Name & Degree
Gennaro Martines, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Cyanoacrylate to Stop Bleeding After EMR for Large Polyps

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