Medical Treatment Versus Surgery in Stricturing Small Bowel Crohn's Disease

• Status: Not yet recruiting
• Trial end date: 2027-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Collaborator: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Treatments: Azathioprine; Infliximab

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Adults under guardianship, safeguard justice or trusteeship

• Pregnant or breastfeeding female

• Acute bowel obstruction requiring urgent surgical intervention

• Suspected or confirmed gastrointestinal perforation

• Concurrent active perianal sepsis

• Internal fistulizing disease in association with strictures

• Colonic stenosis and/or colonic active disease at screening endoscopy

• Contra-indication to surgery, general anesthesia, anti-TNF, thiopurines

• Use of corticosteroids (prednisolone > 20 mg daily or equivalent) within 4 weeks prior to visit V0

• Treatment with any biologics within 8 weeks before visit V0

• Presence of a stoma

• HIV/HCV/HBV infection