cholestatic itch cholestatic pruritus
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
12 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject should: 1. Be able to provide informed consent 2. Meet the criteria of one of the following subgroups: a) Patients of >=18 years of age who are diagnosed with non-hereditary hepatobiliary diseases leading to cholestasis e.g.: Primary sclerosing cholangitis (PSC) • Based on: elevated serum alkaline phosphatase and *GT and characteristic lesions on ERCP and/or magnetic resonance cholangiopancreaticography (MRCP) Primary biliary cholangitis (PBC) • Based on >=2 of 3 criteria: history of elevated alkaline phosphatase for at least 6 months, liver biopsy consistent with PBC, positive anti-mitochondrial antibody titer (or when low in titer anti-GP210 and/or anti-SP100 and/or anti-PDC-E2 antibodies) Malignant cholestatic diseases (e.g. cholangiocarcinoma) • Based on the criteria of the subdiagnosis. b) Patients prone to hereditary cholestatic diseases (patients of =18 years of age who are prone to intrahepatic cholestasis of pregnancy (ICP). • Based on: pruritus in pregnancy, elevated serum ALT activities and fasting bile acid levels, and exclusion of other causes of liver dysfunction or itching. Serum liver tests and fasted bile acids should normalize after pregnancy.
Exclusion criteria
Exclusion criteria: Subjects who could be considered as a vulnerable population will be excluded from participation in this study: 1. Clinically unstable subjects (as assessed by their treating physician) 2. Subjects with a confirmed infection 3. Subjects with a dermatologic disease other than the skin phenotype associated with cholestasis 4. Subjects admitted to the ICU 5. Subjects experiencing itch as a result of cholestasis for less than three months 6. Subject who are prone to another hepatic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess oxylipin levels in itching cholestatic patients and compare the levels of these compounds with non-itching cholestatic patients and healthy controls. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondly, to investigate the association of itch and elevated levels of oxylipins (OXLAMs, OXAAMs) in serum and skin in different subgroups. Thirdly, to asses if lipoxygenases are expressed in elevated levels, and thereby are the main source of oxylipins in patients with cholestatic itch. Fourthly, to evaluate the effect of known therapies for cholestatic itch on lipoxygenase expression and oxylipin levels. Fifthly, to determine the tissue of origin of these oxylipins (skin and/or leukocytes) Lastly, we want to identify the lipoxygenase(s) responsible for the production of pruritogenic oxylipins found in itching cholestatic patients. | — |
Countries
Netherlands
Outcome results
None listed