Does Routine Submucosal Injection Improve Complete Resection of 4-20 mm Neoplastic Colorectal Polyps?
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04548947|
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : July 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Procedure: Cold snare polypectomy in conjunction with a submucosal injection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||435 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||prospective, multi-endoscopist, single center, clinical study at tertiary referral center (CHUM)|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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
- Delayed bleeding complications [ Time Frame: 14 days after the initial procedure ]bleeding after the end of the initial procedure 14 days later
- 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
- 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
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
|Contact: Maureen Fontaine||(514) 890-8000 ext email@example.com|
|Centre Hospitalier Universitaire de Montréal||Recruiting|
|Montréal, Quebec, Canada|
|Contact: Maureen Fontaine 514-890-8000 ext 30655 firstname.lastname@example.org|
|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|