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

Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Status: Unknown

Conditions: Chronic Inflammation; Crohn's Disease; Stenosis

Treatments: Device: A balloon dilatation; Device: Placing a self-expanding metallic stent

Study type: Interventional

Funder types: Other

Identifiers

NCT02395354

ProtDilat-3-2013

Details and patient eligibility

About

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.

Full 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

Enrollment: 122 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

Placing a self-expanding metallic stent

Other group

Description:

Placing a self-expanding metallic stent

Treatment:

Device: Placing a self-expanding metallic stent

A balloon dilatation

Other group

Description:

A balloon dilatation

Treatment:

Device: A balloon dilatation