Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGroupe d'Etude Therapeutique des Affections Inflammatoires Digestives

About this trial

Inflammatory Bowel Disease (IBD) patients have an increased risk of ColoRectal Cancer (CRC). The cumulative risk of CRC development is estimated at 1% after 10 years of disease progression, 2% after 20 years, and 5% after more than 20 years of disease progression (1). The incidence of CRC in IBD has gradually declined, attributed to enhanced detection of preneoplastic lesions (dysplasia), improved adherence to screening recommendations, utilization of advanced high-definition endoscopes (2-4), and the implementation of more efficacious therapeutic strategies (5-9).

Presently, there is no consensus on the endoscopic management of dysplastic lesions. Recent techniques such as submucosal dissection (ESD) enable the resection of non-polypoid flat lesions larger than 2 cm. Lesions previously treated with colectomy can now be resected by ESD with en-bloc resection rates of approximately 85.7% (17). However, long-term data on the risk of local or distant recurrence after endoscopic resection in IBD is lacking. It is crucial to evaluate complete (R0) and curative resection rates, as well as the rate of local recurrence, based on the type of endoscopic treatment.

In light of the 21st century advancements, characterized by high-definition endoscopes and targeted treatments, it is imperative to:

* Assess the prevalence and incidence of dysplasia in IBD and its risk of progression to CRC. * Specifically characterize the endoscopy and histology of pre-neoplastic lesions in IBD to facilitate better selection of lesions amenable to endoscopic treatment or surgery. * Evaluate the rates of local and distant recurrence over time, considering factors associated with this evolving risk (IBD characteristics, endoscopic appearance, histology, type of resection, etc.).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients age ≥ 18 years

Documented diagnosis of CD or UC established based on standard clinical, endoscopic and histological criteria.

IBD (CD/UC) evolving for more than 8 years, or for ≥1 year if associated with Primary Sclerosing Cholangitis (PSC)

For UC: Extended ulcerative colitis (E2 or E3 in the Montreal classification)

Disqualifiers

Patient followed for ileal Crohn's disease (L1)

Patient followed for rectal ulcerative colitis (E1)

Patient referred for a therapeutic endoscopic procedure, without prior or subsequent follow-up in the participating center

Patients < 18 years old

Trial population

All IBD patients requiring colonoscopy for screening or treatment of dysplasia are eligible for inclusion. All consecutive patients from selected centers meeting the inclusion criteria will be included.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

To evaluate the prevalence of dysplasia in patients with IBD at high risk of preneoplastic lesions followed prospectively in a screening program at the time of high-definition endoscopes.

The primary endpoint is the prevalence of dysplasia in IBD patients at high risk of dysplasia estimated at their first endoscopy in the study.

Time frame
"From enrollment to the end of study at 7 years"

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Lead sponsor

AFA Crohn /RCH

Collaborator

Société Nationale Française de Gastroentérologie

Collaborator

This trial is not recruiting at the moment. You can still explore other options: