|- candidate number||3622|
|- NTR Number||NTR1378|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-jul-2008|
|- Secondary IDs|| |
|- Public Title||Endoscopic Balloon Dilatation of narrowed intestinal connection in Crohn's disease with or without extra local medication|
|- Scientific Title||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
|- hypothesis||It is beneficial to add 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.
|- Healt Condition(s) or Problem(s) studied||Crohn's disease, Triamcinolone injections, Anastomosis, Ileocecal resection, Stenosis , Endoscopic balloon dilatation|
|- 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
- 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||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
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2008|
|- planned closingdate||1-okt-2008|
|- Target number of participants||36|
|- 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 be performed.
- Colonoscopy with fluoroscopy under conscious sedation.
- Asessment of Rutgeerts score during colonoscopy.
- An EBD will be performed during the same colonoscopy session.
- At defined points blood samples will be taken
|- Primary outcome||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.|
|- Secondary outcome||- 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
|- Timepoints||- Triamcinolone injection therapy combined with 9 mg oral BudenoFalk once daily for 24 weeks |
- 1/10/2008 - 1/10/2010
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Drs. C.G. Noomen|
|- CONTACT for SCIENTIFIC QUERIES||Drs. C.G. Noomen|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC), Department of Gastroenterology and Hepatology|
(Source(s) of Monetary or Material Support)
|Leiden University Medical Center (LUMC), Department of Gastroenterology and Hepatology|
|- Brief summary||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|
|- Main changes (audit trail)|
|- RECORD||14-jul-2008 - 25-jul-2008|