Stricture Definition and Treatment (STRIDENT) Endoscopic Therapy Study

St Vincent's Hospital Melbourne

Status: Unknown

Conditions: Stricture; Bowel; Inflammatory Bowel Diseases; Crohn Disease

Treatments: Procedure: Intensive endoscopic stricture dilatation; Procedure: Standard (single) endoscopic stricture dilatation

Study type: Interventional

Funder types: Other

Identifiers

NCT03222011

StVincentsMelbourneSTRIDENT2

Details and patient eligibility

About

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.

Full description

Prospective randomised controlled study. Patients with Crohn's Disease and symptomatic stricture(s) will undergo randomisation to receive standard or intensive endoscopic therapy.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Standard endoscopic therapy

Active Comparator group

Description:

Single endoscopic dilatation

Treatment:

Procedure: Standard (single) endoscopic stricture dilatation

Intensive endoscopic therapy

Experimental group

Description:

3 endoscopic dilatations 3 weeks apart and possible needle knife strictureplasty

Treatment:

Procedure: Intensive endoscopic stricture dilatation