Endoscopic Balloon Dilatation of stenotic ileocecal anastomosis in Crohn*s disease with or without additive local steroid injection and oral Budenofalk* a double-blind, randomized, parallel group trial

Completed

• Conditions: Gut obstruction; 10018008; stenosis

• Registration Number: NL-OMON38167
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 42

Inclusion Criteria

• Informed consent
• Man or woman 18 years or older
• Established diagnosis of Crohn*s disease
• Negative stool culture (at screening visit, 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 decrase in calibre of the intestinal lumen with or without a pre-stenotic dilatation) located at the anastomosis as diagnosed with MR enterography and transabdominal ultrasound

Exclusion Criteria

• 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 stenosis at the site of the anastomosis`
• The concomitant use of other oral drugs containing budesonide. A washout period of four weeks is applied.
• 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate whether the addition of intensive local anti-inflammatory therapy<br /><br>reduces the recurrence of stenosis and/or need for surgical intervention in<br /><br>routine enteric balloon dilatation in Crohn*s disease patients with symptomatic<br /><br>stenosis of the anastomosis.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess the feasibility and value of radiologic imaging of the anastomosis in<br /><br>the endoscopy suite, and validating Radiological Crohn*s Disease Anastomotic<br /><br>Index (RCDAI). </p><br>