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

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.

Conditions

• Crohn Disease

Interventions

PROCEDURE

Colonoscopy

The colonoscopy will be performed at 3 or 6 months after surgery according to FC: * In patients with FCP \>=150µg/g at around 3 months after surgery, a colonoscopy will be immediately performed * In patients with FCP \<150µg/g at around 3 months after surgery, the colonoscopy will be organized at 6 months after surgery Colonoscopy will be performed using high definition white-light endoscopy (HD-WLE) followed by virtual chromoendoscopy (VCE). The neoterminal ileum, ileocolic anastomosis and right colon will be assessed. A follow-up colonoscopy will be performed within 18 months after index colonoscopy, as standard of care.

PROCEDURE

Intestinal biopsies

During index colonoscopy, at least 2 biopsies from each of the segments will be taken as standard of practice to assess inflammation in post-operative CD. Only in Irish sites, twelve biopsies - four in the area of ileocolonic anastomosis, four in the neo-terminal ileum and four in the colon just distal to the anastomosis- will be taken for research purposes, in addition to standard-of-care biopsies.

PROCEDURE

Confocal laser endomicroscopy

pCLE with fluorescein injection will be performed during index colonoscopy, in centres where is available, to assess early alteration of the barrier function.

PROCEDURE

Intestinal ultrasound

All patients will undergo a cross-sectional imaging test as part of their standard of care at 3 and 6 months after surgery. A follow-up IUS will be performed within 18 months after index colonoscopy, as standard of care.

DIAGNOSTIC_TEST

Stool

Stool samples will be collected at 3 and 6 months after surgery and used for faecal calprotectin analysis. Research stool will be collected during the visit of index colonoscopy and at 12 months after index colonoscopy for metagenomics (only in Irish sites).

DIAGNOSTIC_TEST

Blood

Blood will be collected at 3 and 6 months after surgery and used as standard of care. Research blood will be collected during the visit of index colonoscopy and at 12 months after index colonoscopy for research - i.e. proteomic, genomic, cell experiments (only in Irish sites).

DIAGNOSTIC_TEST

Saliva

Saliva will be collected during the visit of index colonoscopy and at 12 months after surgery for research - i.e. optical spectroscopy (only in Irish site)

OTHER

Clinical follow-up

Patients will be followed-up at 6, 12 and 24 months after index endoscopy. Patients will be evaluated in clinic or by telephone call and the disease will be reassessed. The following scores will be repeated: Harvey Bradshaw Index (HBI) and CD Activity Index score (CDAI). Participants will give an update on their medication use.

Sponsors & Collaborators

• The Leona M. and Harry B. Helmsley Charitable Trust

  collaborator OTHER

• University College Cork

  lead OTHER

Principal Investigators

• Marietta Iacucci, Professor · APC Microbiome Ireland, University College Cork

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-01

Primary Completion

2025-10-31

Completion

2026-05-31

Countries

• Belgium
• Canada
• Germany
• Ireland
• Israel
• Italy

Study Locations