No registrations found.
ID
Source
Brief title
Health condition
Inflammatory bowel disease, azathioprine, 6-mercaptopurine, 6-thioguanine, hepatotoxicity, liver biopsy.
Chronisch inflammatoir darmlijden, azathioprine, 6-mercaptopurine, 6-thioguanine, levertoxiciteit, leverbiopsie.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Histopathologically proven nodular regenerative hyperplasia or sinusoidal dilatation.
Secondary outcome
1. Ratio of [6-mercaptoribonucleotides] and [6-thioguanine nucleotides];
2. Liver test abnormailities;
3. Demographic information.
Background summary
Thiopurines, such as azathioprine, 6-mercaptopurine and 6-thioguanine are increasingly used in the treatment of the inflammatory bowel diseases Crohn's disease and ulcerative colitis. Thiopurine therapy, 6-thioguanine therapy in particular, has been related with the occurence of hepatotoxicity. At present there are no studies in which the hepatotoxicity of these thiopurines are being compared by means of histopathological evaluation. This study will give more insight in the hepatotoxicity of these drugs in inflammatory bowel disease patients, which may have implications for the long-term use of these drugs.
Study objective
Long-term use of 6-thioguanine is more hepatotoxic, based on histopathological findings, as compared with the long-term use of azathioprine and 6-mercaptopurine in inflammatory bowel disease patients.
Study design
After identification and when written informed consent is obtained, patients will visit the hospital onze for the above mentioned interventions.
Intervention
1. Liver biopsy;
2. Venapuncture;
3. Abdominal ultrasonography;
4. Physical examination;
5. A questionnaire.
VU University Medical Center,
De boelelaan 1118
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4440613
d.vanasseldonk@vumc.nl
VU University Medical Center,
De boelelaan 1118
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4440613
d.vanasseldonk@vumc.nl
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
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
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 | NL1878 |
| NTR-old | NTR1992 |
| Other | METC VUMC : 09/030 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |