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

C

Centre hospitalier de l'Université de Montréal (CHUM)

Status

Completed

Conditions

Colorectal Cancer

Treatments

Procedure: Cold snare polypectomy in conjunction with a submucosal injection

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

429 patients

Sex

All

Ages

45 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

429 participants in 1 patient group

Cold snare polypectomy with a submucosal injection
Experimental group
Description:
The procedure will include a cold snare polypectomy with a submucosal injection done prior to the resection.
Treatment:
Procedure: Cold snare polypectomy in conjunction with a submucosal injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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