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Clinical Studies in Primary Sclerosing Cholangitis (PSC)

The main aim of the clinical studies in primary sclerosing cholangitis (PSC) is to determine effective means of treatment and diagnosis.

Primary sclerosing cholangitis (PSC) constitutes an important part of the patients seen at Department of Gastroenterology, Oslo University Hospital, Rikshospitalet. The Clinical PSC Research Group focus their effort on improving diagnosis, treatment and follow-up of PSC patients.

We collaborate closely with the Clinical Liver Research Group at Haraldsplass Deaconess Hospital in Bergen, led by Mette Vesterhus, the Epigenetics Group at the Department of Cancer Prevention, Institute for Cancer Research at the Norwegian Radium Hospital, led by Guro E. Lind, the International PSC Study Group (IPSCSG) and the European Network for the Study of Cholangiocarcinoma (ENSCCA).

Clinical trials and drug development

PSC is a slowly progressive disease which in most cases has a course of one to two decades from the identification of early stages until end-stage liver disease. It has been difficult to establish a robust level of evidence supporting an effect of treatment in delaying liver transplantation.

At present, no medical therapy with proven efficacy is available, but several promising compounds are being investigated in phase I, II and phase III trials. 

The Norwegian PSC research center participates in the phase III nor-ursodeoxycholic acid trial from Falk Pharmaceutical company. We aim to initiate and take part in more clinical trials in the near future. 

Another focus area the of the Norwegian PSC research center over recent years has been to molecularly characterize cholangiocarcinoma tumors arising in the context of PSC to be able to provide personalized treatment to PSC patients affected by cholangiocarcinoma

Biomarker development

A key topic for the clinical research group is the identification of biomarkers for disease severity and prognosis, including markers to determine the effect of medical treatment.

We were the first to demonstrate and validate the strong prognostic power of the ELFTM test in PSC, leading to current recommendations for its use in PSC in international guidelines. 

We are now investigating biomarkers in blood, bile and stool, along with evaluation of novel imaging modalities, with the aim of developing tools to improve clinical trials design and guide personalized patient management. 
Patients are also closely followed after liver transplantation to determine factors that contribute to the development of recurrent primary sclerosing cholangitis disease.

Another priority topic is to determine markers for early diagnosis and screening of  cholangiocarcinoma in patients with PSC to allow for early intervention and curative treatment. 

Large patient panels,high-quality clinical data and biological samples are needed to provide sufficient level of evidence for novel biomarkers.
For that purpose, we have established a national prospective cohort as part of ScandPSC (Strategic Prospective Scandinavian PSC biobank) - a collaboration with Karolinska University Hospital, Nasjonalt nettverk for autoimmune leversykdommer at Haraldsplass Diakonale Sykehus (in Norwegian), in addition to the large retrospective Norwegian PSC biobank at Oslo University Hospital Rikshospitalet.

Patient care development

Symptoms, like pruritus and fatigue, and concerns may affect the quality of life of patients living with PSC. We have documented this in Norwegian patients.

In an ongoing project, we search for “the compound that leads to itch” in cholestatic pruritus with the aim of identifying potential druggable targets.

Moreover, we contribute to the development of PSC-specific instruments for patient-reported outcomes which will allow us to gauge the patient experience of effect in clinical trials.

Collaboration

Current diagnosis of PSC relies on imaging demonstrating scarring of the bile ducts.

Ideally, we would like to establish diagnostic markers for PSC, in patients with inflammatory bowel disease, that can be detected before the scarring of the bile ducts has become irreversible.

In collaboration with IBSEN - the Inflammatory Bowel Disease in South-Eastern Norway study group, ongoing efforts aim to determine factors that correlate with sub-clinical bile duct changes on cholangiography in patients with inflammatory bowel disease.

The majority of the studies within the clinical research groups are performed in close collaboration with

We also collaborate with

Key investigators in the clinical research groups are clinicians, mostly funded by Oslo University Hospital and Haraldsplass Deaconess Hospital.
Some dedicated time for research is supported by the Norwegian PSC Research Center.

Publications 2022

  • Early and accurate detection of cholangiocarcinoma in patients with primary sclerosing cholangitis by methylation markers in bile. Hepatology. 2022
  • Cholangiocarcinoma landscape in Europe: Diagnostic, prognostic and therapeutic insights from the ENSCCA Registry. J Hepatol. 2022.
  • Algebraic topology-based machine learning using MRI predicts outcomes in primary sclerosing cholangitis. Eur Radiol. Exp. 2022
  • Portal fibroblast with mesenchymal stem cell features form a reservoir of proliferative myofibroblast in liver fibrosis. Hepatology. 2022
Published July 4, 2022 3:22 PM - Last modified Dec. 15, 2023 11:25 AM

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