Stricture Definition and Treatment (STRIDENT) Drug Therapy Study

• Status: Active, not recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Two thirds of patients with Crohn's disease require intestinal surgery at some time in their life. Intestinal strictures, that is narrowing of the bowel due to inflammation and scarring, are the most common reason for surgery. Despite the high frequency, associated disability, and cost there are no are no treatment strategies that aim to improve the outcome of this disease complication. The STRIDENT (stricture definition and treatment) studies aim to develop such strategies.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St Vincent's Hospital Melbourne
• Collaborators: AbbVie; Australasian Gastro Intestinal Research Foundation
• Treatments: Adalimumab

Criteria

Inclusion Criteria:

• Inflammatory bowel disease patients with intestinal stricture(s) identified on CT, MRI or endoscopy.

Exclusion Criteria:

• Acute bowel obstruction requiring urgent surgical intervention

• Deemed by treating physician to have high risk of acute bowel obstruction

• Concurrent active perianal sepsis

• Internal fistulising disease in association with strictures (entero-enteric stulas)

• Low rectal or anal strictures

• Evidence of dysplasia or malignancy from stricture biopsies or adjacent mucosal biopsies

• Patients for whom endoscopy is not suitable due to co-morbidities or clinical state

• Inability to give informed consent

• Suspected perforation of the gastrointestinal tract

• Pregnancy

• Inability to undergo MRI small bowel due to a contraindication.