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

McMaster University

Status: Unknown

Conditions: Crohn Disease

Treatments: Procedure: Surgery; Procedure: TTS balloon dilation

Study type: Interventional

Funder types: Other

Identifiers

NCT03735355

TTS Surgery Crohns Stricture

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Balloon dilation

Experimental group

Description:

TTS balloon dilation

Treatment:

Procedure: TTS balloon dilation

Surgery

Active Comparator group

Description:

Resection of the fibrostenotic area

Treatment:

Procedure: Surgery