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

NCT ID: NCT03735355

Last Updated: 2018-11-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2022-02-28

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.

Conditions

Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Balloon dilation

TTS balloon dilation

Group Type: EXPERIMENTAL

TTS balloon dilation

Intervention Type: PROCEDURE

Dilation of a stricture using TTS balloon

Surgery

Resection of the fibrostenotic area

Group Type: ACTIVE_COMPARATOR

Surgery

Intervention Type: PROCEDURE

Surgical resection of fibrostenotic area

Interventions

Surgery

Surgical resection of fibrostenotic area

Intervention Type: PROCEDURE

TTS balloon dilation

Dilation of a stricture using TTS balloon

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Mohammad Yaghoobi

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 26928961 (View on PubMed)

Other Identifiers

TTS Surgery Crohns Stricture

Identifier Type: -

Identifier Source: org_study_id