ENDO ACE TRIALEndoscopic Balloon Dilatation of stenotic ileocecal anastomosis in Crohn´s disease with or without additive local steroid injection and oral Budenofalk;a randomized controlled trial - ENDO ACE TRIA
- Conditions
- Crohn's disease.Patients with Crohn's disease with status after ileocecal resection. Stenotic ileocecal anastomosis with symptoms of obstruction.MedDRA version: 14.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders
- Registration Number
- EUCTR2007-005455-42-NL
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 42
Informed consent
•Man or woman between 18 and 75 years of age
•Established diagnosis of Crohn’s disease
Negative stool culture (for exclusion of infectious ileocolitis and Clostridium Difficile infection)
•History of ileocecal resection
•= 2 symptoms of intestinal obstruction
-Intermittent abdominal pain
-Abdominal distension
-Nausea
-Vomiting
-Anorexia
•Significant stenotic segment (defined as a decrease in calibre of the intestinal lumen with or without a pre-stenotic dilatation) located at the anastomosis as diagnosed with MR enterography and abdominal ultrasound.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•A stenotic segment of more than 5 cm
•Rutgeerts score i4 inflammation at the site of stenosis
•Fistulas at the site of stenosis or in the near proximity
•A stenosis that cannot be properly endoscopically visualized
•A significant stenosis proximal to the stenotic anastomosis
•The concomitant use of other oral drugs containing budesonide within 4 weeks of screening
•Pregnancy, lactation, or intended pregnancy within 9 months
•Serious secondary illnesses of an acute or chronic nature (e.g., acute cardiovascular disease, active infection)
•Known intolerance/hypersensitivity to the study drug
•Well-founded doubt about the patient’s cooperation and/or compliance
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to evaluate the benefit of adding intensive local anti-inflammatory therapy (Triamcinolone injection therapy combined with 9 mg oral BudenoFalk once daily for 24 weeks) to routine enteric balloon dilatation in Crohn´s disease patients with symptomatic anastomosis;Secondary Objective: To assess the feasibility and value of radiologic imaging of the anastomosis in the endoscopy suite, and validating Radiological Crohn´s Disease Anastomotic Index (RCDAI). <br><br>;Primary end point(s): To evaluate whether the addition of intensive local anti-inflammatory therapy reduces the recurrence of stenosis and/or need for surgical intervention in routine enteric balloon dilatation in Crohn´s disease patients with symptomatic stenosis of the anastomosis.<br><br>
- Secondary Outcome Measures
Name Time Method