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

Not Applicable

• Conditions: Stenosis; Crohn's Disease; Chronic Inflammation
• Interventions: Device: Placing a self-expanding metallic stent; Device: A balloon dilatation

• Registration Number: NCT02395354
• Lead Sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

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

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2015-03-17
• Study First Submitted QC: 2015-03-17
• Study First Posted: 2015-03-23
• Primary Completion: 2017-09
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-11
• Last Update Posted: 2018-04-13
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 122

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placing a self-expanding metallic stent	Placing a self-expanding metallic stent	Placing a self-expanding metallic stent
A balloon dilatation	A balloon dilatation	A balloon dilatation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Hospital Unversitari Mutua de Terrasa; 🇪🇸 Terrassa, Barcelona, Spain