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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease
• Intervention / Treatment: Diagnostic test: Intestinal ultrasound

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Maarten Pruijt, MD, PhD candidate; Phone Number: +31650091289; Email: m.j.pruijt@amsterdamumc.nl
• Study Contact Backup: Name: Krisztina Gecse, MD, PhD; Phone Number: +31-20-566-4401; Email: k.b.gecse@amsterdamumc.nl

Study Locations

• Germany
  • Lüneburg, Germany, 21339
    • Not yet recruiting
    • Klinikum Luneburg
    • Contact: Prof. Kucharzik MD, PhD; Email: Torsten.Kucharzik@klinikum-lueneburg.de
    • Sub-Investigator: Torsten Kucharzik, Prof MD PhD
  • Oldenburg, Germany, 26123
    • Not yet recruiting
    • Hospital of Oldenburg
    • Contact: Ulf Helwig, MD, PhD; Email: helwig@internisten-ol.de
    • Sub-Investigator: Ulf Helwig, MD, PhD
• Italy
  • Rozzano
    • Milano, Rozzano, Italy, 20089
      • Not yet recruiting
      • Instituto Clinico Humanitas IRCSS
      • Contact: Mariangela Allocca, MD, PhD; Email: mariangela.allocca@hunimed.eu
      • Sub-Investigator: Mariangela Allocca, MD, PhD
• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105AZ
      • Recruiting
      • Amsterdam UMC
      • Contact: Krisztina Gecse, MD, PhD; Phone Number: +31-20-566-4401; Email: k.b.gecse@amsterdamumc.nl
      • Principal Investigator: Krisztina Gecse, MD, PhD
      • Sub-Investigator: Maarten Pruijt, MD, PhD candidate
• United Kingdom
  • London, United Kingdom
    • Not yet recruiting
    • Guy's and St. Thomas' Hospitals
    • Contact: Peter Irving, MD, PhD; Email: peter.irving@gstt.nhs.uk
    • Sub-Investigator: Peter Irving, MD, PhD
    • Sub-Investigator: Andrea Centritto, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult patients with an established diagnosis of CD going through ileocecal resection	Diagnostic test: Intestinal ultrasound; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 10, 2022
• Primary Completion (ANTICIPATED): December 1, 2024
• Study Completion (ANTICIPATED): May 1, 2025

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: January 27, 2023
• First Posted (ACTUAL): February 6, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: January 27, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Recurrence; Crohn Disease
• Other Study ID Numbers: W21_405 # 21.452

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No