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

Not Applicable

• Conditions: Crohn Disease
• Interventions: Procedure: TTS balloon dilation; Procedure: Surgery

• Registration Number: NCT03735355
• Lead Sponsor: McMaster University

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

1. Pre-recruitment phase including proposal, IRB approval, staff training, budget transfer - 9 months

2. Recruitment of patients: 2 years

3. Follow up: 2 years

4. 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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-05
• Study First Submitted QC: 2018-11-06
• Last Update Submitted: 2018-11-06
• Study First Posted: 2018-11-08
• Last Update Posted: 2018-11-08
• Study Start: 2019-04-01
• Primary Completion: 2021-06-30
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 40 Patients with Crohns disease and a short stricture (<5 cm) within the reach of upper or lower GI endoscopy

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Exclusion Criteria

• Abscess or phlegmon
• Fistula
• High-grade dysplasia
• Malignancy
• Previous intervention
• Pregnant women

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Balloon dilation	TTS balloon dilation	TTS balloon dilation
Surgery	Surgery	Resection of the fibrostenotic area

Primary Outcome Measures

Name	Time	Method
Surgery-free period in patients with fibrostenotic Crohns disease	2 years	The time to the need for first surgical treatment in following study intervention in each group