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

NCT05713409 | Unknown

• 1 other identifier: W21_405 # 21.452
• Study Type: observational
• Target: 120
• Locations: 4 countries
• Sites: 5

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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• • 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

Study Arms (1)

Adult patients with an established diagnosis of CD going through ileocecal resection

Diagnostic Test: Intestinal ultrasound

Interventions

Intestinal ultrasound DIAGNOSTIC_TEST

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.

Adult patients with an established diagnosis of CD going through ileocecal resection

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with established Crohn's disease going through ICR will be eligible for inclusion

You may qualify if:

• confirmed diagnosis of Crohn's disease
• undergoing ICR (or re-resection)
• ≥16 years of age

You may not qualify if:

• \<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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (5)

Klinikum Lüneburg

Lüneburg, 21339, Germany

NOT YET RECRUITING

Hospital of Oldenburg

Oldenburg, 26123, Germany

NOT YET RECRUITING

Instituto Clinico Humanitas IRCSS

Milan, Rozzano, 20089, Italy

NOT YET RECRUITING

Amsterdam UMC

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

Guy's and St. Thomas' Hospitals

London, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Maarten Pruijt, MD, PhD candidate

CONTACT

+31650091289; m.j.pruijt@amsterdamumc.nl

Krisztina Gecse, MD, PhD

CONTACT

+31-20-566-4401; k.b.gecse@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 6, 2023
• Study Start: February 10, 2022
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: February 6, 2023

Record last verified: 2023-01

Locations

GB (1); NL (1); DE (2); IT (1)