Endoscopic Balloon Dilation vs Surgery to Treat Short Strictures in Fibrostenosing Crohns Disease: An RCT
Primary Purpose
Crohn Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Surgery
TTS balloon dilation
Sponsored by
About this trial
This is an interventional treatment trial for Crohn Disease
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Balloon dilation
Surgery
Arm Description
TTS balloon dilation
Resection of the fibrostenotic area
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03735355
Brief Title
Endoscopic Balloon Dilation vs Surgery to Treat Short Strictures in Fibrostenosing Crohns Disease: An RCT
Official Title
Endoscopic Balloon Dilation as Compared to Surgical Management for the Treatment of Short Strictures in Fibrostenosing Crohns Disease: A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Anticipated)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
February 28, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
- 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Balloon dilation
Arm Type
Experimental
Arm Description
TTS balloon dilation
Arm Title
Surgery
Arm Type
Active Comparator
Arm Description
Resection of the fibrostenotic area
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Surgical resection of fibrostenotic area
Intervention Type
Procedure
Intervention Name(s)
TTS balloon dilation
Intervention Description
Dilation of a stricture using TTS balloon
Primary Outcome Measure Information:
Title
Surgery-free period in patients with fibrostenotic Crohns disease
Description
The time to the need for first surgical treatment in following study intervention in each group
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26928961
Citation
Rieder F, Latella G, Magro F, Yuksel ES, Higgins PD, Di Sabatino A, de Bruyn JR, Rimola J, Brito J, Bettenworth D, van Assche G, Bemelman W, d'Hoore A, Pellino G, Dignass AU. European Crohn's and Colitis Organisation Topical Review on Prediction, Diagnosis and Management of Fibrostenosing Crohn's Disease. J Crohns Colitis. 2016 Aug;10(8):873-85. doi: 10.1093/ecco-jcc/jjw055. Epub 2016 Feb 29.
Results Reference
background
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Endoscopic Balloon Dilation vs Surgery to Treat Short Strictures in Fibrostenosing Crohns Disease: An RCT
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