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

April 11, 2018 updated by: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Barcelona
      • Terrassa, Barcelona, Spain, 08221
        • Recruiting
        • Hospital Unversitari Mutua de Terrasa
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carme Loras, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage (%) of free patients of therapeutic intervention (dilatation, prosthesis or surgery) for symptomatic recurrence at one year follow-up
Time Frame: 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).
one year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of free patients of therapeutic intervention (dilatation, prosthesis or surgery) for symptomatic recurrence at 6 months follow-up.
Time Frame: 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).
At 6 months follow-up
Rate of complications related to the procedure.
Time Frame: 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
one year follow-up
The procedure total costs
Time Frame: 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
one year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Investigators

  • Principal Investigator: Carme Loras, MD, Hospital Universitari Mutua de Terrassa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2013

Primary Completion (Actual)

September 1, 2017

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

March 17, 2015

First Submitted That Met QC Criteria

March 17, 2015

First Posted (Estimate)

March 23, 2015

Study Record Updates

Last Update Posted (Actual)

April 13, 2018

Last Update Submitted That Met QC Criteria

April 11, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ProtDilat-3-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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