Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Location status: Recruiting
Location contact
Daniel Von Renteln, MD
PRINCIPAL_INVESTIGATOR
Julie Fleury
CONTACT
514-890-8000 ext. 30917
Roupen Djinbachian, MD
SUB_INVESTIGATOR
NCT Number: NCT05355363
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.
Interested in participating?
Request Info45 year–80 year
All sexes
Interventional
Not applicable
Montreal, Quebec, Canada
Location status: Recruiting
Daniel Von Renteln, MD
PRINCIPAL_INVESTIGATOR
Julie Fleury
CONTACT
514-890-8000 ext. 30917
Roupen Djinbachian, MD
SUB_INVESTIGATOR
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard colonoscopy: All optically diagnosed polyps will be removed and sent to the CHUM pathology laboratory for histopathological evaluation according to institutional standards.
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)]
Time frame: 1 year
the rate of metachronous high-risk adenoma (HRA) after index detection of high-grade dysplasia (HGD)
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
Time frame: 1 year
The rate of T-MAN detection according to number, size, location, and dysplasia status of index SSPs
Time frame: 1 year
The rate of metachronous HRA detection for index HGD alone
Time frame: 1 year
The rate of metachronous HRA detection for index HGD according to number, size, location, of index HGD
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
Time frame: 1 year
The 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 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 detection according to number, size, location, and dysplasia status of index SSPs
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
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
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
Contact information is provided by the study sponsor or research team.
Centre hospitalier de l'Université de Montréal (CHUM)
Other
Acronym: SSL follow-up
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