Endoscopic Balloon Dilation vs Surgery to Treat Short Strictures in Fibrostenosing Crohns Disease: An RCT

Study Overview
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Brief Summary
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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
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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. - An interim analysis will be performed after 20 cases complete the study Sample Size 40 patients randomized to two arms undergoing TTS dilation or surgical managements Statistical analysis Comparisons between groups will be done using Student's t-test. Qualitative variables will be summarized as a percentage of the group total and comparisons between groups will be based on the chisquared test. The cumulative relapse rate of each treatment group will be estimated by the Kaplan±Meier method and the difference between treatment groups will be tested by the log rank test. Time to relapse will be compared betweens two groups using a Cox proportional hazards regression analysis. A P value of less than 0.05 is considered to be signicant.

Official Title
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Endoscopic Balloon Dilation as Compared to Surgical Management for the Treatment of Short Strictures in Fibrostenosing Crohns Disease: A Randomized Controlled Trial.

Conditions
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Crohn Disease

Intervention / Treatment
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* Procedure: Surgery
* Procedure: TTS balloon dilation


Participation Criteria
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Eligibility Criteria
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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 Fistula High-grade dysplasia Malignancy Previous intervention Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Balloon dilation<br>TTS balloon dilation | Procedure: TTS balloon dilation<br>* Dilation of a stricture using TTS balloon<br>|
| Active Comparator: Surgery<br>Resection of the fibrostenotic area | Procedure: Surgery<br>* Surgical resection of fibrostenotic area<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgery-free period in patients with fibrostenotic Crohns disease | The time to the need for first surgical treatment in following study intervention in each group | 2 years |