comparative prospective multicenter randomized study of endoscopic treatment of stenosis in crohn´s disease

Conditions: Stenosis; Crohn's Disease; Chronic Inflammation

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.

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

Eligibility criteria:
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 \ 1.8)

Keywords: endoscopic treatment stenosis crohn's disease balloon dilatation self-expanding metallic stent chronic transmural inflammation steady narrowing of the intestinal lumen