Primary sclerosing cholangitis Primary sclerosing cholangitis
Conditions
Interventions
Treatment using non-invasive low-frequency therapy devices covered by insurance for painful conditions
Sponsors
Kuwatani Masaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Individuals aged 18 years or older at the time of consent acquisition 2) Individuals diagnosed with PSC based on clinical symptoms and pathological examination 3) Individuals with serum alkaline phosphatase (ALP) levels at least 1.5 times the upper limit of normal, or an Anali score*9,10 (described later) of 1 or higher. 4) Individuals evaluated by MRCP (or US/CT if MRCP imaging is difficult) within the past 6 months. 5) Individuals who, after receiving sufficient explanation regarding participation in this study, can actively understand the informed consent document themselves and provide written consent of their own free will.
Exclusion criteria
Exclusion criteria: 1) Individuals with chronic diseases other than PSC (viral hepatitis, metabolic liver disease, alcoholic liver disease, primary biliary cholangitis, Wilson's disease, etc.) 2) Patients with liver damage that has progressed beyond a certain level (serum AST or ALT note) exceeding 10 times the normal upper limit 3) Individuals with a history of progressive brain lesions 4) Individuals undergoing vagus nerve stimulation therapy 5) Individuals with a history of severe cardiovascular disease 6) Pregnant or lactating individuals 7) Individuals with skin hypersensitivity and a history of skin symptoms caused by metals, etc. 8) Individuals who have difficulty ingesting orally 9) Individuals with severe renal impairment (estimated glomerular filtration rate (eGFR) less than 30 ml/min) 10) Individuals using cardiac pacemakers or implantable cardioverter-defibrillators (ICDs) 11) Individuals with glycerin hypersensitivity 12) Individuals who have difficulty operating the low-frequency therapy device (ESPUERGE) or maintaining usage records 13) Other individuals deemed unsuitable as research subjects by the principal investigator or co-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum ALP levels and Anali score changes over time from baseline to 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Safety during low-frequency therapy administration and occurrence of adverse events 2) Changes in liver function markers (serum total bilirubin, ALT, AST, gamma-GTP) from baseline to 52 weeks 3) Changes in severity diagnosis assessed by Child-Pugh classification from baseline to 52 weeks 4) Disease activity in cases with inflammatory bowel disease 5) Presence of abdominal pain/abdominal discomfort/skin itching, and its temporal changes when present: evaluated using a 10-point visual analogue scale (VAS) 6) Immune cell localization before and after low-frequency therapy; expression positivity and intensity of molecules induced by inflammation; presence of disease-related gene variants and their association with disease status. Correlation between inflammatory status and histopathological factors and expression levels of other analyzed molecules. | — |
Contacts
Public ContactMasaki Kuwatani
Hokkaido Univerisity
Outcome results
None listed