The primary goal of the study is the prevalence of NRH in patients with IBD, who have been treated for at least five years with azathioprin or 6-mercaptopurin. A MRI of the liver, using the Seiderer protocol, and a percutaneous liver biopsy will be…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
prevalence of NRH (histologically) with percutaneous liver biopsy
prevalence of NRH with MRI, uing the Seiderer protocol, sensitivity and
specificity compared to histology.
Secondary outcome
Secundary goals are the correlation between NRH and the cumulative dose of
azathioprin and 6-mercaptopurin and the correlation between NRH and the 6-TGN
levels.
Other secundary goals are the correlation between radiological and histological
findings and correlation between radiological or histological findings and
blood constituents (livertests and thrombocytes).
Background summary
Azathioprine and 6-mercaptopurine are widely used in the treatment of
inflammatoru bowel disease. 6-Thioguanin (Lanvis) was introduced in 2001,
because this thiopurine is closely related to the active 6TGN metabolites.
With 6-thioguanin a high frequency of Nodular regenerative hyperplasia has been
reported.
Liver biopsy is most sensitive for detecting NRH and MRI has been suggested as
an alternative diagnostic test.
Study objective
The primary goal of the study is the prevalence of NRH in patients with IBD,
who have been treated for at least five years with azathioprin or
6-mercaptopurin. A MRI of the liver, using the Seiderer protocol, and a
percutaneous liver biopsy will be performed.
Secundary goals are the correlation between NRH and the cumulative dose of
azathioprin and 6-mercaptopurin and the correlation between NRH and the 6-TGN
levels.
Other secundary goals are the correlation between radiological and histological
findings and correlation between radiological or histological findings and
blood constituents (livertests and thrombocytes).
Study design
Observational
Study burden and risks
Burden:
1. MRI-liver:
- one hour
- no radiation is used, specfic contra-indications.
2. ultrasonography monitored percutaneous liver biopsy
- 3,5 hour
- before the biopsy venapunction
- afterwards observation
Risks:
2. Liver biopsy:
- 25% mild pain inupper quadrant or right shoulder; mild hypotension
- Risks; bleeding: 0.3%, infection and hemobilia 0.1%. Motality: 1 in 10.000 to
1 in 12.000
Postbus 5800
6202 AZ Maastricht
Nederland
Postbus 5800
6202 AZ Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
IBD patients
18 years or older
who have been treated at least 5 years with azathioprine and/or 6-mercaptopurine
who give permission for ultrasound guided liverbiopsy and MRI
Exclusion criteria
anaemia (Hb < 6.5 mmol/L), thrombocytopenia (Thr < 50 * 10 9/L), prolonged INR (INR > 1.5), ascites.
exclusioncriteria for MRI: pacemaker, ICD, metal intracerebral clips, known allergy for contrast agents that are used, claustrophobia.
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 |
|---|---|
| CCMO | NL20965.096.08 |