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

Last updated: February 7, 2025
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colorectal Cancer

Rectal Cancer

Cancer

Treatment

Standard Colonoscopy

Clinical Study ID

NCT05355363
22.179
  • Ages 45-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  1. Patients with a diagnosis of inflammatory bowel disease;
  1. Hereditary CRC syndromes;
  1. CRC at index colonoscopy;
  1. Serrated polyposis syndrome;
  1. Life expectancy too short to benefit from colonoscopy;
  1. Follow-up colonoscopy not yet due according to USMSTF guidelines. Patients withconcomitant HRA and SL at index will be invited to participate if the index (orlast) colonoscopy was performed more than 1 year ago. This is based on the highrates of HRA we identified in our retrospective study posing increased risksfor these patients.

Study Design

Total Participants: 730
Treatment Group(s): 1
Primary Treatment: Standard Colonoscopy
Phase:
Study Start date:
February 27, 2023
Estimated Completion Date:
December 31, 2025

Study 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).

Connect with a study center

  • Centre Hospitalier de l'Université de Montréal

    Montréal, Quebec
    Canada

    Active - Recruiting

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