Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05355363

Risk of Metachronous Findings After Detection of Serrated Lesions and High-grade Dysplasia With Surveillance Delay

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Location status: Recruiting

Location contact

Daniel Von Renteln, MD

PRINCIPAL_INVESTIGATOR

Julie Fleury

CONTACT

[email protected]

514-890-8000 ext. 30917

Roupen Djinbachian, MD

SUB_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard Colonoscopy

Diagnostic Test

Standard colonoscopy: All optically diagnosed polyps will be removed and sent to the CHUM pathology laboratory for histopathological evaluation according to institutional standards.

Primary outcomes

  1. Rate of TMAN detection after index detection of serrated lesions

    Time frame: 1 year

    the rate of total metachronous advanced neoplasia (TMAN) detection after index detection of serrated lesions [sessile serrated polyps (SSPs), traditional serrated adenomas (TSAs)]

  2. Rate of metachronous high-risk adenoma (HRA) after index detection of high-grade dysplasia (HGD)

    Time frame: 1 year

    the rate of metachronous high-risk adenoma (HRA) after index detection of high-grade dysplasia (HGD)

Secondary outcomes

  1. Rate of T-MAN detection for concomitant index SSP+low-risk adenoma (LRA); index SSP+ high-risk adenoma (HRA); index SSP alone

    Time frame: 1 year

    The rate of T-MAN detection for concomitant index SSP+low-risk adenoma (LRA); index SSP+ high-risk adenoma (HRA); index SSP alone

  2. Rate of T-MAN detection according to number, size, location, and dysplasia status of index SSPs

    Time frame: 1 year

    The rate of T-MAN detection according to number, size, location, and dysplasia status of index SSPs

  3. Rate of metachronous HRA detection for index HGD alone

    Time frame: 1 year

    The rate of metachronous HRA detection for index HGD alone

  4. Rate of metachronous HRA detection for index HGD according to number, size, location, of index HGD

    Time frame: 1 year

    The rate of metachronous HRA detection for index HGD according to number, size, location, of index HGD

  5. 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

    Time frame: 1 year

    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

  6. Rate of metachronous high-risk SL detection according to number, size, location, and dysplasia status of index SSPs

    Time frame: 1 year

    The rate of metachronous high-risk SL detection according to number, size, location, and dysplasia status of index SSPs

  7. 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

    Time frame: 1 year

    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

  8. Rate of metachronous HRA detection according to number, size, location, and dysplasia status of index SSPs

    Time frame: 1 year

    The rate of metachronous HRA detection according to number, size, location, and dysplasia status of index SSPs

  9. Rate of T-MAN and metachronous HRA detection for the serrated lesion (SL) and HGD groups

    Time frame: 1 year

    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

  10. Rate of metachronous advanced SL and metachronous HRA detection for the serrated lesion (SL) group

    Time frame: 1 year

    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

  11. Adenoma detection rates (ADR) and advanced adenoma detection rates at follow-up

    Time frame: 1 year

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel von Renteln, MD, PhD

CONTACT

[email protected]

514-890-8000

Julie Fleury

CONTACT

[email protected]

514-890-8000 ext. 30655

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Acronym: SSL follow-up

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 2, 2022
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.