Prediction and Close Monitoring of Postoperative Recurrence by Intestinal Ultrasound After Ileocecal Resection in Crohn's Disease Patients

Study Overview
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Brief Summary
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Crohn's disease (CD) is an inflammatory bowel disease causing chronic transmural inflammation followed by intestinal complications including strictures and penetrating lesions such as fistulas and abscesses. 30-50% of the CD patients will require surgery during the course of their disease. Unfortunately, resection is not curative and endoscopically recurrent lesions (i.e. endoscopic recurrence) are observed in 65-90% of patients within 12 months, and in 80-100% within 3 years after the operation. Eventually 15-20% of patients will require new surgery within 5 years. Close monitoring for postoperative recurrence is therefore needed to perform early intervention and prevent clinical recurrence and need for re-surgery. Endoscopy is the gold standard to assess postoperative disease recurrence however it's limited by its invasiveness. Cross sectional imaging is known for accurate detection of postoperative recurrence. Intestinal ultrasound (IUS) of the colon and (neo)terminal ileum correlates well with CT, MRE and colonoscopy findings in the postoperative setting. IUS is non-invasive, cheap, readily available and may show early, signs of disease recurrence. Therefore it could be a useful tool to predict endoscopic recurrence at 6 months.

Official Title
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Prediction and Close Monitoring of Postoperative Recurrence by Using Intestinal Ultrasonography After Ileocecal Resection in Crohn's Disease Patients

Conditions
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Crohn Disease

Intervention / Treatment
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* Diagnostic Test: Intestinal ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: confirmed diagnosis of Crohn's disease undergoing ICR (or re-resection) ≥16 years of age Exclusion Criteria: <16 years of age Inability to give informed consent Ongoing gastroenteritis Deviating stoma (Sub)total colectomy Obesity (BMI >35 kg/m²) Insufficient visualization of the anastomosis AND the neo-terminal ileum at baseline IUS

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult patients with an established diagnosis of CD going through ileocecal resection<br> | Diagnostic Test: Intestinal ultrasound<br>* As part of the routine care, patients will undergo ileocolonoscopy at 6 months, IUS will be performed 3, 6, 12, 18, 24, 30 and 36 months (using B-mode and CDS) and at 3 and 6 months elastography will be performed on the neo-terminal ileum. Biomarkers (CRP and fecal calprotectine) will be measured according to routine care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary aim of the study is to investigate if IUS (as measured by B-mode and CDS) in combination with faecal calprotectin at 3 months after ICR is an early surrogate marker of endoscopic disease recurrence (as defined by a RS ≥ i2) at 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • To assess if IUS (as measured by B-mode, CDS and SWE) alone at 3 months after ICR is an early surrogate marker of endoscopic disease recurrence (as defined by a RS ≥ i2) at 6 months |  | 6 months | 
| to assess if IUS (as measured by B-mode, CDS and SWE) alone or in combination with faecal calprotectin at 6 months after ICR is accurate in detecting endoscopic recurrence at 6 months (as defined by a RS score ≥ i2 and by the SES-CD˃3) |  | 6 months | 
| to develop an IUS score for postoperative recurrence in Crohn's disease |  | 6 months | 
| to assess if IUS (as measured by B-mode, CDS and SWE) alone or in combination with faecal calprotectin at 12 months after ICR is a surrogate marker of endoscopic disease recurrence (RS≥ 2) at 18 months and/or clinical outcomes at 18, 24, 30 and 36 months |  | 12-36 months | 
| to compare IUS (as measured by B-mode, CDS and SWE; alone or in combination with faecal calprotectin) and the RS upon endoscopy at 6 months after ICR for their prognostic role on clinical outcomes upon 3 years of follow-up |  | 6 - 36 months | 
| to assess if SWE during IUS at 3, 6 and 12 months is predictive of anastomotic stenosis upon follow-up |  | 3-12 months | 
| to assess the feasibility of IUS in the postoperative settings for different types of anastomosis |  | 3-6 months | 
| to assess the diagnostic accuracy of FCal at 3 and 6 months to predict and determine endoscopic disease recurrence, respectively |  | 3-6 months |