Endoscopic Balloon Dilation as Compared to Surgical Management for the Treatment of Short Strictures in Fibrostenosing Crohns Disease: A Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- McMaster University
- Enrollment
- 40
- Primary Endpoint
- Surgery-free period in patients with fibrostenotic Crohns disease
Study Overview
Brief Summary
There is currently no standard management to guide the clinicians in treating patients with fibrostenotic disease. European Crohns and Colitis Organization [ECCO] recently developed a topical review on prediction, diagnosis and management of fibrostenosing Crohns disease. The review suggests endoscopic balloon dilation, strictureplasty, and intestinal resection as reasonable treatment options for short strictures based on the low grade of evidence.
Detailed Description
Study Population All patients with Crohns disease and a short stricture (<5 cm) within the reach of upper or lower GI endoscopy
Study Timeline
- Pre-recruitment phase including proposal, IRB approval, staff training, budget transfer - 9 months
- Recruitment of patients: 2 years
- Follow up: 2 years
- Analysis and preparing report: 6 months
Study Design Single blind randomized controlled trial The data will be blindly analyzed. Double blinding is not possible due to the nature of the study.
Study Methods Please see the study flow diagram below. Randomization will be done using computer software generating random numbers. Outcome Measures - A research associate will contact patients on weeks 1,2,4 and months 3,6,12,18 and 24 to record the items mentioned as secondary objectives of the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •40 Patients with Crohns disease and a short stricture (<5 cm) within the reach of upper or lower GI endoscopy
Exclusion Criteria
- •Abscess or phlegmon
- •High-grade dysplasia
- •Malignancy
- •Previous intervention
- •Pregnant women
Arms & Interventions
Balloon dilation
TTS balloon dilation
Intervention: TTS balloon dilation (Procedure)
Surgery
Resection of the fibrostenotic area
Intervention: Surgery (Procedure)
Outcomes
Primary Outcomes
Surgery-free period in patients with fibrostenotic Crohns disease
Time Frame: 2 years
The time to the need for first surgical treatment in following study intervention in each group
Secondary Outcomes
No secondary outcomes reported
Investigators
Mohammad Yaghoobi
Assistant Professor of Medicine
McMaster University