TRansmural hEaliNg Definition in CroHn's Disease (TRENCH 1)
TRansmural hEaliNg Definition in CroHn's Disease - The TRENCH1 Study
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
210 participants
Sep 28, 2023
OBSERVATIONAL
Conditions
Summary
Multicenter prospective cross-sectional study of CD patients, its aim is the construction of an objective and reproducible system for evaluation of Transmural healing in Crohn's Disease (CD). Primary objective : Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD
Eligibility
Inclusion Criteria6
- ≥ 18 years of age
- Patient diagnosed with CD for more than 6 months with histological confirmation available in his medical record.
- Indication for MRE based on routine clinical practice validated by the treating physician
- Any CD treatment will be authorized, such as biologicals (infliximab, adalimumab, vedolizumab, ustekinumab…), or immunomodulators (azathioprine, 6-mercaptopurine, methotrexate…).
- The subjects sign and date a written, informed consent form and any required privacy authorization prior to the initiation of the study.
- A subject can be enrolled into the study only if the grade of TH (assessed by the LRP) corresponding to the subject is not already fulfilled.
Exclusion Criteria11
- Pregnancy during the study
- People unable to give consent (because of their physical or mental state)
- Absence of written consent
- Ulcerative colitis or unclassified IBD
- Specific postsurgical settings: ileoanal anastomosis, ileostomy or colostomy.
- Less than 3 evaluable ileocolic segments or more than 3 resected ileocolonic segments (not counting ileocecal valve)
- Severe obstructive symptoms
- Symptomatic intra-abdominal abscess
- Contraindication for MRI
- Isolated perianal disease without luminal location
- MRE images of poor quality, based on previously defined criteria
Interventions
MRE performed as part of the standard of care follow up of the patient, the exam will be recorded for the study and analysed by central readers.
Locations(18)
View Full Details on ClinicalTrials.gov
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NCT05903066