Clinical trial NCT04548947: 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
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: colorectal cancer
incomplete resection rate
submucosal injection
neoplastic polyps
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 429
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, multi-endoscopist, single center, clinical study at tertiary referral center (CHUM)
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Incomplete resection rate (IRR)
timeFrame: Day 1
Secondary outcomes:
measure: Immediate bleeding complications
timeFrame: Day 1
measure: Delayed bleeding complications
timeFrame: 14 days after the initial procedure
measure: Other severe complications
timeFrame: 14 days after the initial procedure
measure: Proportion of polyps considered interpretable for complete polyp removal
timeFrame: 14 days after the initial procedure
measure: Incomplete resection of colorectal polyps
timeFrame: 14 days after the initial procedure
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier Universitaire de Montréal
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Daniel von Renteln, MD
role: PRINCIPAL_INVESTIGATOR
References: