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

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ClinicalTrials.gov Identifier: NCT04548947
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : July 15, 2021
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: Cold snare polypectomy in conjunction with a submucosal injection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 435 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: prospective, multi-endoscopist, single center, clinical study at tertiary referral center (CHUM)
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Does Routine Submucosal Injection Improve Complete Resection of 4-20 mm Neoplastic Colorectal Polyps?
Actual Study Start Date : January 12, 2021
Actual Primary Completion Date : July 1, 2021
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: Cold snare polypectomy with a submucosal injection
The procedure will include a cold snare polypectomy with a submucosal injection done prior to the resection.
Procedure: Cold snare polypectomy in conjunction with a submucosal injection
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 Measures :
  1. Incomplete resection rate (IRR) [ Time Frame: Day 1 ]
    The number of incomplete polyps resected after polypectomy, as defined by any neoplastic tissue found in marginal biopsies.


Secondary Outcome Measures :
  1. Immediate bleeding complications [ Time Frame: Day 1 ]
    bleeding requiring endoscopic intervention either during colonoscopy/polypectomy, or requiring an immediate second intervention such as surgery and/or hospital admission

  2. Delayed bleeding complications [ Time Frame: 14 days after the initial procedure ]
    bleeding after the end of the initial procedure 14 days later

  3. Other severe complications [ Time Frame: 14 days after the initial procedure ]
    Post-polypectomy syndrome and perforation requiring endoscopic intervention and/or surgery, and/or hospital admission

  4. Proportion of polyps considered interpretable for complete polyp removal [ Time Frame: 14 days after the initial procedure ]
    Proportion of polyps considered interpretable for complete polyp removal



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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04548947


Contacts
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Contact: Maureen Fontaine (514) 890-8000 ext 30655 maureen.fontaine.chum@ssss.gouv.qc.ca

Locations
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Canada, Quebec
Centre Hospitalier Universitaire de Montréal Recruiting
Montréal, Quebec, Canada
Contact: Maureen Fontaine    514-890-8000 ext 30655    maureen.fontaine.chum@ssss.gouv.qc.ca   
Contact: Daniel von Renteln, MD         
Principal Investigator: Daniel von Renteln, MD         
Sub-Investigator: Simon Bouchard, MD         
Sub-Investigator: Erik Deslandres, MD         
Sub-Investigator: Mickael Bouin, MD         
Sub-Investigator: Audrey Weber, MD         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT04548947    
Other Study ID Numbers: 20.111
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: July 15, 2021
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
colorectal cancer
incomplete resection rate
submucosal injection
neoplastic polyps
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases