Chronic Inflammation, Crohn's Disease, Stenosis
Conditions
Keywords
Endoscopic treatment, Stenosis, Crohn's Disease, balloon dilatation, self-expanding metallic stent, chronic transmural inflammation, steady narrowing of the intestinal lumen
Brief 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
Interventions
DEVICEPlacing 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.
DEVICEA 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.
Sponsors
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage (%) of free patients of therapeutic intervention (dilatation, prosthesis or surgery) for symptomatic recurrence at one year follow-up | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of free patients of therapeutic intervention (dilatation, prosthesis or surgery) for symptomatic recurrence at 6 months follow-up. | 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). |
| Rate of complications related to the procedure. | one year follow-up | 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 |
| The procedure total costs | one year follow-up | 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 |
Countries
Spain
Contacts
Primary ContactCarme Loras, MD
Backup ContactMaría Esteve, MD
Outcome results
None listed