Crohn's Disease Clinical Trial
Official title:
Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease: Metal Self-expanding Prosthesis Balloon Dilatation
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.
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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