Health TrialsbyHealthPanel

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

ConditionCrohn Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorUniversity College Cork

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Inability to provide consent.

Presence of serious co-morbidities (clinical contraindication).

Presence of ostomy.

Pregnancy or breastfeeding.

Trial population

Males and females aged between 18 and 75 years old and with an established diagnosis of CD, who have undergone surgery no more than three months before study entry, or have surgery planned, will be consecutively recruited after obtaining written consent. The sample size for the study is 225

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Colonoscopy

    Procedure/Surgery

    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.

  • Intestinal biopsies

    Procedure/Surgery

    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.

  • Confocal laser endomicroscopy

    Procedure/Surgery

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

  • Intestinal ultrasound

    Procedure/Surgery

    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.

  • Stool

    Diagnostic test

    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).

  • Blood

    Diagnostic test

    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).

  • Saliva

    Diagnostic test

    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)

  • Clinical follow-up

    Other intervention

    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.

Treatment groups

225 Participants
are divided into 1 treatment group
Group A: Post-operative CD8 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
3 months or 6 months
2

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

Time frame
3 months and 6 months

Secondary outcomes

1

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.

Time frame
1 year and 2 years
2

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

Time frame
3 months or 6 months
3

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

Time frame
3 months or 6 months

Other outcomes

Sponsors and contacts

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

University College Cork

Lead sponsor

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator

Source ClinicalTrials.gov
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