No registrations found.
ID
Source
Brief title
Health condition
Crohn's disease, ziekte van Crohn
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter will be the accuracy of detecting disease activity and efficacy of DCE MRI at MR in patients with proven Crohn’s disease as compared to histopathology.
Secondary outcome
The secondary study parameters will be the accuracy of detecting disease activity on DCE-MRI as compared to CDAI and CRP. Also the aspect of the bowel wall (serositis or normal) as seen during surgery will be compared to the MRI and the histology.
Background summary
Rationale:
Crohn’s disease (CD) is a transmural inflammatory bowel disease. Grading of severity of disease is important to be able to optimally determine treatment strategy and response to treatment. Abdominal MR-imaging using luminal and intravenous contrast medium combines transmural and extra-intestinal evaluation and can accurately show presence of disease. Moreover, MRI can discriminate between active and fibrotic disease as MRI studies undertaken to determine CD activity in the small and large bowel have indicated that a pathological increase in bowel wall enhancement after intravenous contrast administration of Gadolinium is a useful discriminatory sign of active disease.
Earlier studies have shown that dynamic contrast enhancement curves shown a correlation with active disease in patients with Crohn's disease related perianal fistulas. We expect this also to be the case in luminal Crohn's disease.
Objective:
To determine the correlation between enhancement curves at DCE-MRI and the level of histopathological activity in patients with active luminal CD.
Study design:
Prospective observational study. Patients will undergo a venapuncture and MRI scan as part of clinical routine before surgery. For this study, a dynamic sequence (DCE-MRI) sequence will be made during the MRI scan; therefore the scanning time will be prolonged for 15 minutes. Total scanning time will be 50 minutes. Also, patients have to fill in 1 questionnaire, the CDAI (duration less than 5 minutes). After surgery the resected bowel will be scanned in the MRI for anatomical reference. The inclusion period of the study will be 2 years.
Study population:
Twenty adult patients with proven Crohn’s disease who are scheduled to undergo small-bowel surgery for active M. Crohn will be included after informed consent.
Study objective
To determine the correlation between enhancement curves at DCE-MRI with T1-map and the level of histopathological activity.
Study design
Before surgery, the patient will undergo an abominal MRI.
Intervention
Preoperative MRI with extra dynamic sequence.
M.L.W. Ziech
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5663740
m.l.ziech@amc.uva.nl
M.L.W. Ziech
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5663740
m.l.ziech@amc.uva.nl
Inclusion criteria
1. Proven Crohn's Disease (by endoscopy or histopathology);
2. Scheduled to undergo small-bowel surgery for Crohn's Disease.];
3. Scheduled to undergo a preoperative MRI.
Exclusion criteria
1. Age < 18 years;
2. General contraindications for MRI (pacemaker, claustrophobia, renal insufficiency and pregnancy).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2084 |
| NTR-old | NTR2201 |
| Other | MEC AMC : 08/348 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |