Medical Treatment Versus Surgery in Stricturing Small Bowel Crohn's Disease
ConditionCrohn Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNantes University Hospital
About this trial
The objective of the SMART trial is to compare a combination therapy using azathioprine and subcutaneous infliximab versus ileocecal resection in patients with symptomatic small bowel Crohn's disease.
Eligibility criteria
Qualifiers
Age between 18 and 70 years
Male or female
Documented small bowel CD with intestinal stricture(s) identified on CT, MRI or endoscopy, AND responsible for obstructive symptoms
CREOLE score > 2
Disqualifiers
Adults under guardianship, safeguard justice or trusteeship
Pregnant or breastfeeding female
Acute bowel obstruction requiring urgent surgical intervention
Suspected or confirmed gastrointestinal perforation
Trial design
Treatments tested in this trial
- Azathioprine + infliximab
- Intestinal resection
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Nantes University Hospital
Lead sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Collaborator
Source ClinicalTrials.gov