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UNKNOWNNANCT02395354

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

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...

Lead sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa•1 locations•View source on ClinicalTrials.gov

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Contacts

Carme Loras, MD

CONTACT

+34-937365050 cloras@mutuaterrassa.es

María Esteve, MD

CONTACT

+34-937365050 mestevecomas@telefonica.net

Sponsors

Lead Sponsor

Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

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 1. Screening Visit 2. Sheet Inclusion 3. Expansion notebook / prosthesis placement notebook 4. Monitoring Worksheet to the 7 days. Symptomatic / complications-incidents assessment. 5. Monitoring Worksheet to the 30 days. Symptomatic / complications-incidents assessment. Includes analytical. In case of placement of prostheses include prosthetic removal sheet 6. Monitoring Worksheet to the 2 months. Symptomatic / complications-incidents assessment. 7. Monitoring Worksheet to the 3 months. Symptomatic / complications-incidents assessment. 8. Monitoring Worksheet to the 4 months. Symptomatic / complications-incidents assessment 9. Monitoring Worksheet to the 5 months. Symptomatic / complications-incidents assessment 10. Monitoring Worksheet to the 6 months. Symptomatic / complications-incidents assessment. Include analytical 11. Monitoring Worksheet to the 7 months. Symptomatic / complications-incidents assessment 12. Monitoring Worksheet to the 8 months. Symptomatic / complications-incidents assessment 13. Monitoring Worksheet to the 9 months. Symptomatic / complications-incidents assessment 14. Monitoring Worksheet to the 10 months. Symptomatic / complications-incidents assessment 15. Monitoring Worksheet to the 11 months. Symptomatic / complications-incidents assessment 16. Monitoring Worksheet to the 12 months. Symptomatic / complications-incidents assessment Include analytical. 17. Final assessment. 18. Monitoring Worksheet to the recurrence. Symptomatic / complications-incidents assessment. Include analytical

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 13, 2018Terms

Trial snapshot

StatusUNKNOWN

PhaseNA

Enrollment122

Start dateSep 2013

Last updatedApr 13, 2018

Condition

Stenosis Crohn's Disease Chronic Inflammation

Locations shown

Hospital Unversitari Mutua de Terrasa

Terrassa, Barcelona

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 13, 2018Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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