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

NCT04548947 | Completed

• 1 other identifier: 20.111
• Study Type: interventional
• Target: 429
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

colorectal cancer; incomplete resection rate; submucosal injection; neoplastic polyps

Outcome Measures

Primary Outcomes (1)

• Incomplete resection rate (IRR)

  The number of incomplete polyps resected after polypectomy, as defined by any neoplastic tissue found in marginal biopsies.

  Day 1

Secondary Outcomes (5)

• Immediate bleeding complications

  Day 1

• Delayed bleeding complications

  14 days after the initial procedure

• Other severe complications

  14 days after the initial procedure

• Proportion of polyps considered interpretable for complete polyp removal

  14 days after the initial procedure

• Incomplete resection of colorectal polyps

  14 days after the initial procedure

Study Arms (1)

Cold snare polypectomy with a submucosal injection

EXPERIMENTAL

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

Interventions

Cold snare polypectomy in conjunction with a submucosal injection PROCEDURE

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.

Cold snare polypectomy with a submucosal injection

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed consent form; aged 45-80 years old, indication to undergo a colonoscopy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier Universitaire de Montréal

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Daniel von Renteln, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, multi-endoscopist, single center, clinical study at tertiary referral center (CHUM)

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 16, 2020
• Study Start: January 12, 2021
• Primary Completion: October 1, 2021
• Study Completion: July 1, 2022
• Last Updated: December 8, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)