Risk of Metachronous Findings After Detection of Serrated Lesions and High-grade Dysplasia With Surveillance Delay (SSL follow-up)

The primary aim of this study is to determine the rate of total metachronous advanced neoplasia (TMAN) detection after index detection of serrated lesions (SL) [sessile serrated polyps (SSPs), traditional serrated adenomas (TSAs)], and metachronous high-risk adenoma (HRA) after index detection of high-grade dysplasia (HGD).

We will use the database of patients diagnosed with SL or HGD at index colonoscopy with a delay in surveillance and determine the risk of advanced lesions (especially high-risk lesion and CRC detection) of these delayed colonoscopies. The aim is to determine the effects of breach of continuity of care in these patients.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Colon Adenoma
• Intervention / Treatment: Diagnostic test: Standard Colonoscopy

Detailed Description

Colorectal cancer (CRC) ranks second among worldwide cancer related deaths and third in terms of cancer incidence. Colonoscopy-based screening programs have been established to reduce CRC morbidity and mortality. Multiple guidelines have established surveillance recommendations for repeat colonoscopies based on findings at index colonoscopy. Serrated lesions (SLs), including sessile serrated polyps/adenomas (SSP) and traditional serrated adenomas (TSA) have become of increased interest for their role as precursors of CRC. The optimal timing of follow-up colonoscopies after detection of SLs has been controversial as studies looking into optimal surveillance timing are lacking. The US Multi Society Task Force (USMSTF) 2020 guidelines recommend 5-10y surveillance intervals for detection of 1-2 SSPs, 3-5y for 3-4 SSPs, 3y for >4 SSPs or TSA. In contrast, the 2020 European Society of Gastrointestinal Endoscopy (ESGE) Guidelines state that 1-10mm SLs do not require follow-up. It is unclear what the appropriate surveillance intervals is for patients with SLs which is evidenced by diverging recommendations from USMSTF/ESGE. High-grade dysplasia (HGD) is an exceedingly rare finding in colorectal polyps. The current literature on the yield of colonoscopy after index HGD is sparse, with conflicting data on risk of metachronous HRA due to low numbers of included HGD leading to high variability in reported outcomes.

Patient with SL or HGD diagnosed from 2010-2022 will be gathered from the pathology department to determine which patients lack follow-up during these years. Patients with lack of follow-up will be contacted by phone, then invited to undergo follow-up colonoscopy as part of our routine clinical follow-up of these patients' files.

In addition to the primary and secondary endpoints, data collected will include patient age; sex; ASA class; past medical history; family history of CRC; procedure date; name of endoscopist; colonoscopy indication; BBPS score; withdrawal time; adenoma and polyp detection rate at index and follow-up colonoscopy; completeness of polypectomy; polyp location, size, surface, morphology (Paris classification), histopathology; complications, immediate and late (14 days).

• Study Type: Interventional
• Enrollment (Estimated): 730
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel von Renteln, MD, PhD; Phone Number: 514-890-8000; Email: daniel.von.renteln.med@ssss.gouv.qc.ca
• Study Contact Backup: Name: Julie Fleury; Phone Number: 30655 514-890-8000; Email: julie.fleury.chum@ssss.gouv.qc.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada
      • Recruiting
      • Centre hospitalier de l'Université de Montréal
      • Principal Investigator: Daniel von Renteln, MD
      • Contact: Julie Fleury; Phone Number: 30917 514-890-8000; Email: julie.fleury.chum@ssss.gouv.qc.ca
      • Sub-Investigator: Roupen Djinbachian, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients 45-80 who underwent colonoscopy from 2009 to 2022 at the Montreal University Hospital Center (CHUM) with 1+ SL or HGD detected at index colonoscopy and lacking follow-up within or beyond the surveillance interval recommended by 2020 USMSTF guidelines.

Exclusion Criteria:

• 1) Patients with a diagnosis of inflammatory bowel disease;
• 2) Hereditary CRC syndromes;
• 3) CRC at index colonoscopy;
• 4) Serrated polyposis syndrome;
• 5) Life expectancy too short to benefit from colonoscopy;
• 6) Follow-up colonoscopy not yet due according to USMSTF guidelines. Patients with concomitant HRA and SL at index will be invited to participate if the index (or last) colonoscopy was performed more than 1 year ago. This is based on the high rates of HRA we identified in our retrospective study posing increased risks for these patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colonoscopy; Standard colonoscopy: All optically diagnosed polyps will be removed and sent to the CHUM pathology laboratory for histopathological evaluation according to institutional standards.	Diagnostic test: Standard Colonoscopy; Standard colonoscopy: All optically diagnosed polyps will be removed and sent to the CHUM pathology laboratory for histopathological evaluation according to institutional standards.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of TMAN detection after index detection of serrated lesions	the rate of total metachronous advanced neoplasia (TMAN) detection after index detection of serrated lesions [sessile serrated polyps (SSPs), traditional serrated adenomas (TSAs)]	1 year
Rate of metachronous high-risk adenoma (HRA) after index detection of high-grade dysplasia (HGD)	the rate of metachronous high-risk adenoma (HRA) after index detection of high-grade dysplasia (HGD)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of T-MAN detection for concomitant index SSP+low-risk adenoma (LRA); index SSP+ high-risk adenoma (HRA); index SSP alone	The rate of T-MAN detection for concomitant index SSP+low-risk adenoma (LRA); index SSP+ high-risk adenoma (HRA); index SSP alone	1 year
Rate of T-MAN detection according to number, size, location, and dysplasia status of index SSPs	The rate of T-MAN detection according to number, size, location, and dysplasia status of index SSPs	1 year
Rate of metachronous HRA detection for index HGD alone	The rate of metachronous HRA detection for index HGD alone	1 year
Rate of metachronous HRA detection for index HGD according to number, size, location, of index HGD	The rate of metachronous HRA detection for index HGD according to number, size, location, of index HGD	1 year
Rate of metachronous high-risk serrated lesion (SL) for concomitant index SSP+LRA; index SSP+HRA; index SSP alone; index SSP all synchronous findings included; index TSA a ll synchronous findings included	The rate of metachronous high-risk serrated lesion (SL) for concomitant index SSP+LRA; index SSP+HRA; index SSP alone; index SSP all synchronous findings included; index TSA all synchronous findings included	1 year
Rate of metachronous high-risk SL detection according to number, size, location, and dysplasia status of index SSPs	The rate of metachronous high-risk SL detection according to number, size, location, and dysplasia status of index SSPs	1 year
Rate of metachronous HRA for concomitant index SSP+LRA; index SSP+HRA; index SSP alone; index SSP all synchronous findings included; index TSA all synchronous findings included	The rate of metachronous HRA for concomitant index SSP+LRA; index SSP+HRA; index SSP alone; index SSP all synchronous findings included; index TSA all synchronous findings included	1 year
Rate of metachronous HRA detection according to number, size, location, and dysplasia status of index SSPs	The rate of metachronous HRA detection according to number, size, location, and dysplasia status of index SSPs	1 year
Rate of T-MAN and metachronous HRA detection for the serrated lesion (SL) and HGD groups	The rate of T-MAN and metachronous HRA detection for the serrated lesion (SL) and HGD groups stratified by number of years of surveillance delay	1 year
Rate of metachronous advanced SL and metachronous HRA detection for the serrated lesion (SL) group	The rate of metachronous advanced SL and metachronous HRA detection for the serrated lesion (SL) group stratified by number of years of delay at time of endoscopy from surveillance intervals recommended by guidelines	1 year
Adenoma detection rates (ADR) and advanced adenoma detection rates at follow-up	Adenoma detection rates (ADR) and advanced adenoma detection rates at follow-up stratified by number of years of delay at time of endoscopy from surveillance intervals recommended by guidelines	1 year

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Daniel von Renteln, MD, Centre Hospitalier de l'Universite de Montreal (CHUM)

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 4, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Colonoscopy; sessile serrated polyps; traditional serrated adenomas; high-grade dysplasia; high-risk adenoma; cancer prevention
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: 22.179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No