NCT02395354

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Stenosis
• Crohn's Disease
• Chronic Inflammation

Interventions

Type	Name	Description
DEVICE	Placing a self-expanding metallic stent	* 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.
DEVICE	A balloon dilatation	* 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.

Timeline

• Start date: 2013-09-01
• Primary completion: 2017-09-01
• Completion: 2018-12-31
• First posted: 2015-03-23
• Last updated: 2018-04-13

Locations

1 site across 1 country: Spain