Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease

Study Overview
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Brief Summary
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This study will be a multicentre randomized controlled trial to assess the efficacy between balloon dilatation and self-expanding metallic stent placement for endoscopic treatment of stenosis in Crohn´s Disease.

Detailed Description
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A Prospective, randomized, multicenter clinical trial. Duration: Beginning in mid-2013 with a minimum of three years depending on the patient inclusion rate. The participation of at least 20 hospitals in Spain with an inclusion of about 6 patients per hospital is required. Calculation of sample size: The calculation of sample size was performed considering that the efficacy of endoscopic treatment by endoscopic stent placement is superior to endoscopic dilatation: 75% vs 50% for balloon dilation (% of patients free of therapeutic intervention -endoscopic or surgically a year follow-up). For all 61 patients are required for each treatment group, the total of 122 patients. This calculation is made taking into account: Bilateral Contrast: any two samples may be superior in terms of efficacy. Error type I: 0.05 Error type II: 0.20 (statistical power 80%) Percentage of efficacy at one year follow-up: 75% in the prosthetic group and 50% in the balloon dilatation group Percentage of losses: 5%. Schedule Screening Visit Sheet Inclusion Expansion notebook / prosthesis placement notebook Monitoring Worksheet to the 7 days. Symptomatic / complications-incidents assessment. Monitoring Worksheet to the 30 days. Symptomatic / complications-incidents assessment. Includes analytical. In case of placement of prostheses include prosthetic removal sheet Monitoring Worksheet to the 2 months. Symptomatic / complications-incidents assessment. Monitoring Worksheet to the 3 months. Symptomatic / complications-incidents assessment. Monitoring Worksheet to the 4 months. Symptomatic / complications-incidents assessment Monitoring Worksheet to the 5 months. Symptomatic / complications-incidents assessment Monitoring Worksheet to the 6 months. Symptomatic / complications-incidents assessment. Include analytical Monitoring Worksheet to the 7 months. Symptomatic / complications-incidents assessment Monitoring Worksheet to the 8 months. Symptomatic / complications-incidents assessment Monitoring Worksheet to the 9 months. Symptomatic / complications-incidents assessment Monitoring Worksheet to the 10 months. Symptomatic / complications-incidents assessment Monitoring Worksheet to the 11 months. Symptomatic / complications-incidents assessment Monitoring Worksheet to the 12 months. Symptomatic / complications-incidents assessment Include analytical. Final assessment. Monitoring Worksheet to the recurrence. Symptomatic / complications-incidents assessment. Include analytical

Official Title
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Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease: Metal Self-expanding Prosthesis Balloon Dilatation

Conditions
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Stenosis, Crohn's Disease, Chronic Inflammation

Intervention / Treatment
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* Device: Placing a self-expanding metallic stent
* Device: A balloon dilatation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-75 years. Crohn's Disease with a predominantly fibrotic stenosis de novo and / or post- surgical confirmed by endoscopic and radiological tests, accessible by endoscopy (colonoscopy). Patients with stenosis already known and previously treated with stent and / or dilation with> 1 Year asymptomatic Symptoms of intestinal partial occlusion Refractory to Conventional medical treatment (no response to usual therapeutic range accelerated step-up). Length of stenosis <10 cm. Submit a maximum of 2 stenosis. Patient Informed consent Exclusion Criteria: No patient Informed consent. Stenosis complicated with abscess, fistula or important activity associated with your EC not limited to the stenosis area. Patients with stenosis already known and previously treated with stent and / or dilation with <1 year asymptomatic. Pregnancy and lactation Any clinical situation that prevents the performance of endoscopy Stenosis not accessible by endoscopy Asymptomatic patient Length of stenosis ≥ 10 cm. Submit> 2 stenosis. Severe coagulation disorders (platelets <70000; INR> 1.8)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Placing a self-expanding metallic stent<br>Placing a self-expanding metallic stent | Device: Placing a self-expanding metallic stent<br>* Income on short stay unit (SSU) post-procedure Light sedation by the endoscopist vs anesthetist by center Fully covered self-expanding metal stents Tae Woong Medical® type; prosthesis size at the endoscopist discretion Clips can be placed at the distal end of the prosthesis according to the endoscopist. Prosthesis removal time in 4 weeks.<br>|
| Other: A balloon dilatation<br>A balloon dilatation | Device: A balloon dilatation<br>* Income on short stay unit (SSU) post-procedure Light sedation by the endoscopist vs anesthetist by center. Pneumatic ball type CRE Boston cientific®; balloon diameter at the endoscopist discretion Up to 2 expansion will be made with a minimum interval between 15-30 days between each expansion It shall be deemed failure to expansion if required> 2 expansions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage (%) of free patients of therapeutic intervention (dilatation, prosthesis or surgery) for symptomatic recurrence at one year follow-up | To evaluate the efficacy of endoscopic treatment (prosthesis vs dilation), determined by the percentage of free patients of a new therapeutic intervention (dilatation, prosthesis or surgery) for symptomatic recurrence at one year follow-up. Symptomatic recurrence assessment: It will be performed through an obstructive symptoms scale previously described (Attar et al, Safety and efficacy of extractible self-expandable metal stents in the treatment of Crohn's disease intestinal strictures: A prospective pilot study. Inflamm Bowel Dis. 2011 Dec 11). | one year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of free patients of therapeutic intervention (dilatation, prosthesis or surgery) for symptomatic recurrence at 6 months follow-up. | To evaluate the efficacy of endoscopic treatment (prosthesis vs dilation), determined by the percentage of patients free of therapeutic intervention (dilatation, prosthesis or surgery) for symptomatic recurrence at 6 months follow-up. Symptomatic recurrence assessment: It will be performed through an obstructive symptoms scale previously described (Attar et al, Safety and efficacy of extractible self-expandable metal stents in the treatment of Crohn's disease intestinal strictures: A prospective pilot study. Inflamm Bowel Dis. 2011 Dec 11). | At 6 months follow-up | 
| Rate of complications related to the procedure. | Evaluate the safety and complications of both treatments Immediate complications related to the procedure: None Inhaled into the lungs. Respiratory depression O2 Sat <90% Cardiorespiratory arrest Arrhythmia Allergic reaction Pain Hemorrhage: self-limiting (spontaneous hemostasis) / accurate endoscopic treatment (drooling bleeding / bleeding jet). Piercing: endoscopic treatment / surgery treatment Exitus Others Late complications related to the procedure: Pain Hemorrhage: self-limiting (spontaneous hemostasis) / accurate endoscopic treatment (drooling bleeding / bleeding jet). Piercing: endoscopic treatment / surgery treatment Exitus Others | one year follow-up | 
| The procedure total costs | Evaluate the costs of both treatments Study costs: The calculate procedure of diagnostic test (DT) cost is composed of some premises: Calculate the test unit cost Accounting for all costs associated with DT Direct and Indirect Costs | one year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic treatment, Stenosis, Crohn's Disease, balloon dilatation, self-expanding metallic stent, chronic transmural inflammation, steady narrowing of the intestinal lumen