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

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

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.

Study Overview

• Status: Unknown
• Conditions: Crohn Disease
• Intervention / Treatment: Procedure: TTS balloon dilation; Procedure: Surgery

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Balloon dilation; TTS balloon dilation	Procedure: TTS balloon dilation; Dilation of a stricture using TTS balloon
Active Comparator: Surgery; Resection of the fibrostenotic area	Procedure: Surgery; Surgical resection of fibrostenotic area

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: McMaster University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: November 5, 2018
• First Submitted That Met QC Criteria: November 6, 2018
• First Posted (Actual): November 8, 2018

Study Record Updates

• Last Update Posted (Actual): November 8, 2018
• Last Update Submitted That Met QC Criteria: November 6, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: TTS Surgery Crohns Stricture

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No