Inflammatory bowel disease, azathioprine, 6-mercaptopurine, 6-thioguanine, hepatotoxicity, liver biopsy. Chronisch inflammatoir darmlijden, azathioprine, 6-mercaptopurine, 6-thioguanine, levertoxiciteit, leverbiopsie.
Conditions
Interventions
1. Liver biopsy
2. Venapuncture
3. Abdominal ultrasonography
4. Physical examination
5. A questionnaire.
Sponsors
Department of Gastroenterology and Hepatology, VU University Medical Center, Amsterdam, The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: 1. 18 to 70 years of age; 2. Daignosed with Crohn's disease or ulcerative colitis; 3. Five to ten years use of one type of thiopurine succesively; 4. Obtained written informed consent.
Exclusion criteria
Exclusion criteria: 1. Prior use of azathioprine or 6-mercaptopurine more that one year if using 6-thioguanine; 2. Alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase above twice the upper limit of the normal range; 3. Contraindications for core needle liver biopsy (ascites, suspected malignancy, anemia, low platelet count, prolonged prothrombin time); 4. Pregnancy; 5. (History of) alcohol abuse; 6. Incapacitated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Histopathologically proven nodular regenerative hyperplasia or sinusoidal dilatation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Ratio of [6-mercaptoribonucleotides] and [6-thioguanine nucleotides]; 2. Liver test abnormailities; 3. Demographic information. | — |
Contacts
Public ContactD.P. Asseldonk, van
Outcome results
None listed