AI-enabled Endoscopic Prediction of Post-operative Recurrence in Crohn's Disease
NCT Number: NCT06505304
Acronym: PROSPER
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Crohn Disease
Interventions: PROCEDURE: Colonoscopy|PROCEDURE: Intestinal biopsies|PROCEDURE: Confocal laser endomicroscopy|PROCEDURE: Intestinal ultrasound|DIAGNOSTIC_TEST: Stool|DIAGNOSTIC_TEST: Blood|DIAGNOSTIC_TEST: Saliva|OTHER: Clinical follow-up
Sponsor: University College Cork
Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 225
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-01
Completion Date: 2026-05-31
Locations: University of Leuven, Leuven, Belgium|University of Calgary, Calgary, Canada|University Hospital Erlangen, Erlangen, Germany|Cork University Hospital, Cork, Ireland|Mercy University Hospital, Cork, Ireland|University College Dublin, Dublin, Ireland|University College Hospitals Galway, Galway, Ireland|Rabin Medical Centre, Tel Aviv, Israel|Istituto Clinico Humanitas, Rozzano, Milan, Italy|ASST Spedali Civili, Brescia, Italy|ASST Fatebenefratelli Sacco, Milan, Italy|IRCCS Cà Granda Ospedale Maggiore, Milan, Italy|University Vita-Salute San Raffaele, Milan, Italy|University Federico II, Naples, Italy|IRCCS San Matteo, Pavia, Italy

Summary:
This is a multicentre prospective international observational study. This study aims to introduce a novel multidimensional approach to precision imaging, enabling the identification and stratification of high-risk patients who can potentially benefit from early treatments to halt the progression of Crohn's disease (CD). The investigators will develop a novel endoscopic assessment system using endoscopic enhanced imaging (EEI) to evaluate early post-surgical changes and predict post-operative CD recurrence (POCr). By integrating with immune marker profiling, clinical data, and AI assessment of EEI and histology, the investigators further plan to improve risk stratification and reduce interobserver variability.

Primary Outcome Measures: Early post-operative endoscopic recurrence, Post surgical endoscopic recurrence will be defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) \> 2 and Rutgeerts score \> i2a, 3 months or 6 months|Early post-operative clinical recurrence, Post surgical clinical recurrence will be defined as:

* CD Activity Index score (CDAI) \>200 and a \>70-point increase from baseline, or
* development of a new or re-draining fistula or abscess, or
* requiring steroids, endoscopic dilatation, or hospitalization, 3 months and 6 months
Secondary Outcome Measures: Post-operative clinical recurrence, Post surgical clinical recurrence will be defined as:

* CD Activity Index score (CDAI) \>200 and a \>70-point increase from baseline, or
* development of a new or re-draining fistula or abscess, or
* requiring steroids, endoscopic dilatation, or hospitalization and
* new surgery at 12 and 24 months after colonoscopy., 1 year and 2 years|Early post-operative histological recurrence, Post surgical histologic recurrence will be defined as Robarts histopathology index (RHI) \>3 and PICaSSO Histological remission Index (PHRI) \> 0, 3 months or 6 months|Early post-operative IUS recurrence, Post surgical IUS recurrence will be assessed according to:

* Anastomotic bowel wall thickness (BWT)
* Bowel wall stratification (BWS)
* Lesion length
* Presence of mesenteric lymphadenopathy
* Proliferation of inflammatory mesenteric fat (iFat).
* Presence of free fluid within the peritoneal cavity
* Presence of strictures
* Presence of fistulae
* Presence of abscesses
* Limberg score, 3 months or 6 months