AI-enabled Endoscopic Prediction of Post-operative Recurrence in Crohn's Disease

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• Patients aged between 18 years and 75 years.
• Established diagnosis of CD at least six months prior to study.
• Patients who have undergone intestinal resection within 3 months before study entry or have surgery planned.

🚫 You may not be able to join if…

• Inability to provide consent.
• Presence of serious co-morbidities (clinical contraindication).
• Presence of ostomy.
• Pregnancy or breastfeeding.
• Contraindication for colonoscopy or biopsies.
• Boston Bowel Preparation Scale Score <2 in the rectum plus left-sided colon.

🚫 You may not be able to join if…

• Allergy to nuts or shellfish.
• Severe or uncontrolled asthma.
• Use of beta blockers.
• Previous history of reaction to fluorescein. Patients excluded from pCLE can still enter the study and undergo only standard-of-care endoscopy.

Where this trial is running

• 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

+ 3 more sites.

Who to contact

Michelle O'Riordan · +353 (0)21 4901759 · moriordan@ucc.ie

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06505304.