Clinical trial NCT02395354: Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease
Official title: Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease: Metal Self-expanding Prosthesis Balloon Dilatation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stenosis
Crohn's Disease
Chronic Inflammation
Keywords: Endoscopic treatment
Stenosis
Crohn's Disease
balloon dilatation
self-expanding metallic stent
chronic transmural inflammation
steady narrowing of the intestinal lumen
Lead sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Sponsor class: OTHER
First posted: 2015-03-23
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 \<70000; INR\> 1.8)

Primary outcomes:
measure: Percentage (%) of free patients of therapeutic intervention (dilatation, prosthesis or surgery) for symptomatic recurrence at one year follow-up
timeFrame: one year follow-up
Secondary outcomes:
measure: Percentage of free patients of therapeutic intervention (dilatation, prosthesis or surgery) for symptomatic recurrence at 6 months follow-up.
timeFrame: At 6 months follow-up
measure: Rate of complications related to the procedure.
timeFrame: one year follow-up
measure: The procedure total costs
timeFrame: one year follow-up
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Hospital Unversitari Mutua de Terrasa
state: Barcelona
Study officials:
affiliation: Hospital Universitari Mutua de Terrassa
name: Carme Loras, MD
role: PRINCIPAL_INVESTIGATOR
References:
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