Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT02395354
Study type Interventional
Source Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Contact Carme Loras, MD
Phone +34-937365050
Email cloras@mutuaterrassa.es
Status Recruiting
Phase N/A
Start date September 2013
Completion date December 31, 2018

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03815851 - Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI) in Crohn's Patients After Surgery N/A
Completed NCT02883452 - A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis Phase 1
Recruiting NCT04777656 - Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients. Phase 3
Terminated NCT03017014 - A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions
Recruiting NCT06053424 - Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Healthy Participants and Patients With Crohn's Disease Phase 1
Recruiting NCT05428345 - A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Completed NCT02508012 - Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases N/A
Not yet recruiting NCT02858557 - The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases N/A
Terminated NCT02882841 - MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients N/A
Completed NCT02542917 - Home Versus Postal Testing for Faecal Calprotectin: a Feasibility Study
Terminated NCT02417974 - Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT) Phase 2
Completed NCT03010787 - A First Time in Human Study in Healthy Volunteers and Patients Phase 1
Active, not recruiting NCT02316678 - Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics N/A
Completed NCT02154425 - A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers Phase 1
Completed NCT02193048 - Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
Completed NCT02265588 - Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD). N/A
Completed NCT02197780 - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD N/A
Completed NCT01951326 - Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease Phase 3
Completed NCT01958827 - A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease Phase 3
Recruiting NCT01632462 - A Prospective, Placebo Controlled, Double-Blind, Cross-over Study on the Effects of a Probiotic Preparation (VSL#3) on Metabolic Profile, Intestinal Permeability, Microbiota, Cytokines and Chemokines Expression and Other Inflammatory Markers in Pediatric Patients With Crohn's Disease Phase 4