Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease (PROTDILAT)
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| ClinicalTrials.gov Identifier: NCT02395354 |
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Recruitment Status : Unknown
Verified April 2018 by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa.
Recruitment status was: Recruiting
First Posted : March 23, 2015
Last Update Posted : April 13, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stenosis Crohn's Disease Chronic Inflammation | Device: Placing a self-expanding metallic stent Device: A balloon dilatation | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated 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 : | September 2013 |
| Actual Primary Completion Date : | September 2017 |
| Estimated Study Completion Date : | December 31, 2018 |
| Arm | Intervention/treatment |
|---|---|
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Placing a self-expanding metallic stent
Placing a self-expanding metallic stent
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Device: Placing a self-expanding metallic stent
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A balloon dilatation
A balloon dilatation
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Device: A balloon dilatation
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- 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).
- 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).
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02395354
| Contact: Carme Loras, MD | +34-937365050 ext 1215 | cloras@mutuaterrassa.es | |
| Contact: María Esteve, MD | +34-937365050 | mestevecomas@telefonica.net |
| Spain | |
| Hospital Unversitari Mutua de Terrasa | Recruiting |
| Terrassa, Barcelona, Spain, 08221 | |
| Contact: Carme Loras, MD +34937365050 ext 1215 cloras@mutuaterrassa.es | |
| Contact: Maria Esteve, MD +34937365050 mestevecomas@telefonica.net | |
| Principal Investigator: Carme Loras, MD | |
| Principal Investigator: | Carme Loras, MD | Hospital Universitari Mutua de Terrassa |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa |
| ClinicalTrials.gov Identifier: | NCT02395354 |
| Other Study ID Numbers: |
ProtDilat-3-2013 |
| First Posted: | March 23, 2015 Key Record Dates |
| Last Update Posted: | April 13, 2018 |
| Last Verified: | April 2018 |
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Endoscopic treatment Stenosis Crohn's Disease balloon dilatation |
self-expanding metallic stent chronic transmural inflammation steady narrowing of the intestinal lumen |
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Crohn Disease Inflammation Constriction, Pathologic Pathologic Processes Pathological Conditions, Anatomical |
Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |