Morbus Crohn Status after ileocecal resection Stenosis anastomosis
Conditions
Interventions
- Triamcinolone injection therapy combined with 9 mg oral BudenoFalk once daily for 24 weeks
- IBDQ, Harvey-Bradshaw score and VAS scores will be obtained at defined points.
- MR enterography will
Sponsors
Drs. C.G. Noomen
Department of Gastroenterology
Leiden Universitary Medical Center
Albinusdreef 2
Postbus 9600
2300 RC Leiden
The Netherlands
Tel.: ++31-71-5261838
Fax: ++31-71-5266979
E-mail: c.g.noomen@lumc.nl
Eligibility
Inclusion criteria
Inclusion criteria: 1. Informed consent 2. Man or woman between 18 and 75 years of age 3. Established diagnosis of Crohn's disease 4. Negative stool culture (for exclusion of infectious ileocolitis and Clostridium Difficile infection) 5. History of ileocecal resection 6. 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 causing a pre-stenotic dilatation) located at the anastomosis as diagnosed with MR enterography.
Exclusion criteria
Exclusion criteria: 1. A stenotic segment of more than 6 cm 2. Rutgeerts score i4 inflammation at the site of stenosis 3. Fistulas at the site of stenosis or in the near proximity 4. A stenosis that cannot be properly endoscopically visualized 5. A significant stenosis proximal to the stenotic anastomosis 6. The concomitant use of other oral drugs containing budesonide within 4 weeks of screening 7. Oral antibiotics within 4 weeks of screening. 8. Pregnancy, lactation, or intended pregnancy or intended impregnation within 9 months 9. Serious secondary illnesses of an acute or chronic nature (e.g., acute cardiovascular disease, active infection) 10. Active infection 11. Known intolerance/hypersensitivity to the study drug 12. Well-founded doubt about the patient's cooperation and/or compliance
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| - To assess the feasibility of radiologic imaging of the anastomosis in the endoscopy suite, and validating Radiological Crohn´s Disease Anastomotic Index (RCDAI). - To assess the safety of EBD procedure in combination with local intensive therapy | — |
Primary
| Measure | Time frame |
|---|---|
| To evaluate the benefit of the addition of intensive local anti-inflammatory therapy to routine enteric balloon dilatation in Crohn´s disease patients with symptomatic stenosis of the anastomosis. | — |
Contacts
Public ContactC.G. Noomen
Leiden Universitary Medical Center (LUMC) Department of Gastroenterology Postbus 9600
Outcome results
None listed