Abdominal MRI
ProcedureAbdominal MRI to realize within 4 months following inclusion
NCT Number: NCT02549976
The primary objective is to evaluate digestive damage in CD 5 to 10 years after diagnosis in the GETAID centers included in the RAPID study. Secondary objective is to identify predictive factors of the evolution digestive damage.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Chu Clermont-Ferrand, Clermont-Ferrand, France
Background: Crohn's disease (CD) is a chronic inflammatory disorder of the bowel that is characterized by periods of clinical remission alternating with periods of recurrence. Persistent inflammation is believed to lead to progressive bowel damage that, over time, will manifest in the development of strictures, fistulae, and abscesses. The recent development of the Lemann index allows us to precisely assess digestive damage in CD. The aim of the present study is to evaluate digestive damage and associated predictive factors in CD 5 to 10 years after diagnosis.
Methods: Prospective, multicenter, international, transversal, observational study. Patients who completed the RAPID trial (evaluating the benefits on the course of CD of an early prescription of azathioprine compared with conventional step-care therapy) will be eligible. Digestive damage will be assessed using methods described in the Lemann index protocol, dependent on CD location (abdominal MRI obligatory). The total duration of study participation for 1patient will be ≤4 months.
Aims: The primary objective is to evaluate digestive damage in CD 5 to 10 years after diagnosis in the GETAID centers included in the RAPID study. Secondary objective is to identify predictive factors of the evolution digestive damage.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Abdominal MRI to realize within 4 months following inclusion
Upper endoscopy to realize within 4 months following inclusion
Colonoscopy to realize within 4 months following inclusion
Pelvic MRI to realize within 4 months following inclusion
Time frame: 5 to 10 years after diagnosis
Evaluate digestive damage in Crohn's Disease by using Lemann Index
Time frame: 5 to 10 years after diagnosis
Evaluate digestive damage per organ (upper intestinal tract, small bowel, colon or rectum, anal or perianal) by using Lemann Index
Time frame: 5 to 10 years after diagnosis
Determine correlation between Lemann Index and factors measured at diagnosis and then 5 to 10 years after diagnosis.
Time frame: 5 to 10 years after diagnosis
Variation of Lemann Index 5 to 10 years after diagnosis
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Other
Acronym: DESTIN
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