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

Recruiting

• Conditions: Crohn Disease
• Interventions: Diagnostic Test: Intestinal ultrasound

• Registration Number: NCT05713409
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-10
• Status Verified: 2023-01
• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-01-27
• Last Update Submitted: 2023-01-27
• Study First Posted: 2023-02-06
• Last Update Posted: 2023-02-06
• Primary Completion: 2024-12-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult patients with an established diagnosis of CD going through ileocecal resection	Intestinal ultrasound	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
to assess the diagnostic accuracy of FCal at 3 and 6 months to predict and determine endoscopic disease recurrence, respectively	3-6 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 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 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 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 develop an IUS score for postoperative recurrence in Crohn's disease	6 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

Trial Locations

Locations (5)

Klinikum Lüneburg; 🇩🇪 Lüneburg, Germany

Guy's and St. Thomas' Hospitals; 🇬🇧 London, United Kingdom

Hospital of Oldenburg; 🇩🇪 Oldenburg, Germany

Amsterdam UMC; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Instituto Clinico Humanitas IRCSS; 🇮🇹 Milano, Rozzano, Italy