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Does Routine Submucosal Injection Improve Complete Resection of 4-20 mm Neoplastic Colorectal Polyps?

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cold snare polypectomy in conjunction with a submucosal injection
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring colorectal cancer, incomplete resection rate, submucosal injection, neoplastic polyps

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed consent form; aged 45-80 years old, indication to undergo a colonoscopy

Exclusion Criteria:

  • Known inflammatory bowel disease; active colitis; coagulopathy; familial polyposis syndrome; poor general health, defined as an American Society of Anesthesiologists (ASA) physical status class >3; emergency colonoscopies, hospitalized patients or patients referred from the emergency room.

Sites / Locations

  • Centre Hospitalier Universitaire de Montréal

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cold snare polypectomy with a submucosal injection

Arm Description

The procedure will include a cold snare polypectomy with a submucosal injection done prior to the resection.

Outcomes

Primary Outcome Measures

Incomplete resection rate (IRR)
The number of incomplete polyps resected after polypectomy, as defined by any neoplastic tissue found in marginal biopsies.

Secondary Outcome Measures

Immediate bleeding complications
bleeding requiring endoscopic intervention either during colonoscopy/polypectomy, or requiring an immediate second intervention such as surgery and/or hospital admission
Delayed bleeding complications
bleeding after the end of the initial procedure 14 days later
Other severe complications
Post-polypectomy syndrome and perforation requiring endoscopic intervention and/or surgery, and/or hospital admission
Proportion of polyps considered interpretable for complete polyp removal
Proportion of polyps considered interpretable for complete polyp removal
Incomplete resection of colorectal polyps
Incomplete resection rates of colorectal polyps after widefield resection (defined as resection margins of the largest of 3mm or 25% of the resected polyp size) of 1-20mm polyps using SCALE-EYE as measurement tool vs standard non wide field polypectomy (defined by positive tissue remnants at biopsy sites [vertical and lateral margins, 4 biopsies])

Full Information

First Posted
September 8, 2020
Last Updated
December 6, 2022
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT04548947
Brief Title
Does Routine Submucosal Injection Improve Complete Resection of 4-20 mm Neoplastic Colorectal Polyps?
Official Title
Does Routine Submucosal Injection Improve Complete Resection of 4-20 mm Neoplastic Colorectal Polyps?
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 12, 2021 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

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
This is a prospective, multi-endoscopist, single center, clinical study at tertiary referral center that addresses an important current challenge in the prevention of colorectal cancer (CRC), namely, how to improve the complete removal of CRC precursors. This study will observe the potential benefit of specific polypectomy technique in conjunction with a systematic submucosal injection prior to the polyp resection. This study will evaluate the completeness and incompleteness of the resection of colorectal neoplastic polyps during the procedures.
Detailed Description
Non-detection and incomplete resection of neoplastic colorectal polyps have been identified as the main risk factors for the development of CRC in patients after a colonoscopy. Between 7% and 9% of all newly diagnosed CRCs are estimated to be such "interval cancers," occurring after a previous colonoscopy and before the next surveillance examination. The vast majority of interval cancers are caused by incomplete detection or resection during colonoscopy examination. The contribution of incomplete resection towards interval cancer has recently been pointed out by a panel of experts as one of the cornerstones of CRC prevention that need to be addressed in future research studies. The primary aim of this study is to examine the incomplete adenoma resection rates when performing a cold snare polypectomy in conjunction with a submucosal injection for endoscopic resection of 4-20 mm non-pedunculated colorectal polyps. The subjects are patients, men and women, aged between 45-80 years old that are scheduled for a colonoscopy. The secondary aims are to identify procedure-related complication rates and patient-, polyp-, and endoscopist-related factors associated with incomplete adenoma resection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer, incomplete resection rate, submucosal injection, neoplastic polyps

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective, multi-endoscopist, single center, clinical study at tertiary referral center (CHUM)
Masking
None (Open Label)
Allocation
N/A
Enrollment
429 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cold snare polypectomy with a submucosal injection
Arm Type
Experimental
Arm Description
The procedure will include a cold snare polypectomy with a submucosal injection done prior to the resection.
Intervention Type
Procedure
Intervention Name(s)
Cold snare polypectomy in conjunction with a submucosal injection
Intervention Description
The cold snare polypectomy in conjunction with a submucosal injection is a procedure during which the endoscopist resects the colorectal polyps during a colonoscopy, without any electrocautery.
Primary Outcome Measure Information:
Title
Incomplete resection rate (IRR)
Description
The number of incomplete polyps resected after polypectomy, as defined by any neoplastic tissue found in marginal biopsies.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Immediate bleeding complications
Description
bleeding requiring endoscopic intervention either during colonoscopy/polypectomy, or requiring an immediate second intervention such as surgery and/or hospital admission
Time Frame
Day 1
Title
Delayed bleeding complications
Description
bleeding after the end of the initial procedure 14 days later
Time Frame
14 days after the initial procedure
Title
Other severe complications
Description
Post-polypectomy syndrome and perforation requiring endoscopic intervention and/or surgery, and/or hospital admission
Time Frame
14 days after the initial procedure
Title
Proportion of polyps considered interpretable for complete polyp removal
Description
Proportion of polyps considered interpretable for complete polyp removal
Time Frame
14 days after the initial procedure
Title
Incomplete resection of colorectal polyps
Description
Incomplete resection rates of colorectal polyps after widefield resection (defined as resection margins of the largest of 3mm or 25% of the resected polyp size) of 1-20mm polyps using SCALE-EYE as measurement tool vs standard non wide field polypectomy (defined by positive tissue remnants at biopsy sites [vertical and lateral margins, 4 biopsies])
Time Frame
14 days after the initial procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed consent form; aged 45-80 years old, indication to undergo a colonoscopy Exclusion Criteria: Known inflammatory bowel disease; active colitis; coagulopathy; familial polyposis syndrome; poor general health, defined as an American Society of Anesthesiologists (ASA) physical status class >3; emergency colonoscopies, hospitalized patients or patients referred from the emergency room.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel von Renteln, MD
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Montréal
City
Montréal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Does Routine Submucosal Injection Improve Complete Resection of 4-20 mm Neoplastic Colorectal Polyps?

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