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NCT05713409: INSIGHT

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

Status unknown Last updated 6 February 2023
What this trial tests

trial testing Intestinal ultrasound in Crohn Disease in 120 participants. Status unknown.

Timeline
10 February 2022
Primary endpoint
1 December 2024
1 May 2025

Quick facts

Lead sponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment120
Start date10 February 2022
Primary completion1 December 2024
Estimated completion1 May 2025
Sites5 locations across Italy, Netherlands, Germany, United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) — full company profile →

Who can join

16 and older, any sex, with Crohn Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Intestinal Ultrasound for Monitoring Postoperative Crohn's Disease: A Review and Visual Atlas.
    Gu P, Karime C, Fleshner P, Falloon K, et al · · 2026 · PMID 41335492 · DOI 10.1093/ibd/izaf248

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Other trials of Intestinal ultrasound

Trials testing the same drug.

Other recruiting trials for Crohn Disease

Currently open trials in the same condition.

Other Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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