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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04548947
• Other study ID #: 20.111
• Status: Completed
• Phase: N/A
• Start date: January 12, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: December 2022
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 429
• Est. completion date: July 1, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	Centre Hospitalier Universitaire de Montréal	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Immediate bleeding complications	bleeding requiring endoscopic intervention either during colonoscopy/polypectomy, or requiring an immediate second intervention such as surgery and/or hospital admission	Day 1
Secondary	Delayed bleeding complications	bleeding after the end of the initial procedure 14 days later	14 days after the initial procedure
Secondary	Other severe complications	Post-polypectomy syndrome and perforation requiring endoscopic intervention and/or surgery, and/or hospital admission	14 days after the initial procedure
Secondary	Proportion of polyps considered interpretable for complete polyp removal	Proportion of polyps considered interpretable for complete polyp removal	14 days after the initial procedure
Secondary	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])	14 days after the initial procedure