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.
ID
Bron
Verkorte titel
Aandoening
Inflammatory bowel disease, azathioprine, 6-mercaptopurine, 6-thioguanine, hepatotoxicity, liver biopsy.
Chronisch inflammatoir darmlijden, azathioprine, 6-mercaptopurine, 6-thioguanine, levertoxiciteit, leverbiopsie.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Histopathologically proven nodular regenerative hyperplasia or sinusoidal dilatation.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
After identification and when written informed consent is obtained, patients will visit the hospital onze for the above mentioned interventions.
Onderzoeksproduct en/of interventie
1. Liver biopsy;
2. Venapuncture;
3. Abdominal ultrasonography;
4. Physical examination;
5. A questionnaire.
Publiek
VU University Medical Center,
De boelelaan 1118
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4440613
d.vanasseldonk@vumc.nl
Wetenschappelijk
VU University Medical Center,
De boelelaan 1118
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4440613
d.vanasseldonk@vumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1878 |
| NTR-old | NTR1992 |
| Ander register | METC VUMC : 09/030 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |