Centre Hospitalier Universitaire de Montréal
Montreal, Quebec, Canada
NCT Number: NCT04548947
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.
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Notify Me45 year–80 year
All sexes
Interventional
Not applicable
Montreal, Quebec, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Day 1
The number of incomplete polyps resected after polypectomy, as defined by any neoplastic tissue found in marginal biopsies.
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
Time frame: 14 days after the initial procedure
bleeding after the end of the initial procedure 14 days later
Time frame: 14 days after the initial procedure
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
Time frame: 14 days after the initial procedure
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])
Centre hospitalier de l'Université de Montréal (CHUM)
Other
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