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

Sponsor

Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (Other)

Overall Status

Unknown status

CT.gov ID

NCT02395354

Collaborator

(none)

122

Enrollment

Location

Arms

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stenosis Crohn's Disease Chronic Inflammation	Device: Placing a self-expanding metallic stent Device: A balloon dilatation	N/A

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

Screening Visit
Sheet Inclusion
Expansion notebook / prosthesis placement notebook
Monitoring Worksheet to the 7 days. Symptomatic / complications-incidents assessment.
Monitoring Worksheet to the 30 days. Symptomatic / complications-incidents assessment. Includes analytical. In case of placement of prostheses include prosthetic removal sheet
Monitoring Worksheet to the 2 months. Symptomatic / complications-incidents assessment.
Monitoring Worksheet to the 3 months. Symptomatic / complications-incidents assessment.
Monitoring Worksheet to the 4 months. Symptomatic / complications-incidents assessment
Monitoring Worksheet to the 5 months. Symptomatic / complications-incidents assessment
Monitoring Worksheet to the 6 months. Symptomatic / complications-incidents assessment. Include analytical
Monitoring Worksheet to the 7 months. Symptomatic / complications-incidents assessment
Monitoring Worksheet to the 8 months. Symptomatic / complications-incidents assessment
Monitoring Worksheet to the 9 months. Symptomatic / complications-incidents assessment
Monitoring Worksheet to the 10 months. Symptomatic / complications-incidents assessment
Monitoring Worksheet to the 11 months. Symptomatic / complications-incidents assessment
Monitoring Worksheet to the 12 months. Symptomatic / complications-incidents assessment Include analytical.
Final assessment.
Monitoring Worksheet to the recurrence. Symptomatic / complications-incidents assessment. Include analytical

Study Design

Study Type:

Interventional

Anticipated Enrollment :

122 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease: Metal Self-expanding Prosthesis Balloon Dilatation

Actual Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Sep 1, 2017

Anticipated Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Placing a self-expanding metallic stent Placing a self-expanding metallic stent	Device: Placing 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.
Other: A balloon dilatation A balloon dilatation	Device: A 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.

Arm

Intervention/Treatment

Other: Placing a self-expanding metallic stent

Placing a self-expanding metallic stent

Device: Placing 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.

Other: A balloon dilatation

A balloon dilatation

Device: A 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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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)