An interventional study of Cold snare polypectomy in conjunction with a submucosal injection in Colorectal Cancer, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Completed at 1 site in Canada. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-12-08.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Prevention
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 429 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 370 studies on the registry; 110 are open to participants now.
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Exclusion Criteria:
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)
The number of incomplete polyps resected after polypectomy, as defined by any neoplastic tissue found in marginal biopsies.
Time frame: Day 1
Immediate bleeding complications
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
Delayed bleeding complications
bleeding after the end of the initial procedure 14 days later
Time frame: 14 days after the initial procedure
Other severe complications
Post-polypectomy syndrome and perforation requiring endoscopic intervention and/or surgery, and/or hospital admission
Time frame: 14 days after the initial procedure
Proportion of polyps considered interpretable for complete polyp removal
Proportion of polyps considered interpretable for complete polyp removal
Time frame: 14 days after the initial procedure
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 \[vertical and lateral margins, 4 biopsies\])
Time frame: 14 days after the initial procedure
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Centre hospitalier de l'Université de Montréal (CHUM)