Clinical Research Directory

In-situ vs Ex-situ Liver Preservation

The goal of this Randomized Controlled Trial is to learn what machine preservation method is most clinically effective for liver transplantation (LTx) after donation after circulatory death (DCD). The main questions it aims to answer are: * What perfusion method has the lowest death censored biliary complication rate at 1-year post LT? * Are there differences in the Core Outcome Set of liver transplantation outcomes? * Are there any differences in utilization outcomes? * Are there any differences in cost effectiveness? * Are there any differences in patient quality of life? * Are there any differences in resource utilization? Researchers will compare preservation using in-situ abdominal normothermic regional perfusion (aNRP) to (dual) hypothermic oxygenated perfusion (DHOPE) or DHOPE followed by controlled oxygenated rewarming and normothermic machine perfusion (DHOPE-COR-NMP). Nothing will change from clinical practice for the liver recipients.

Observational Study for the Characterisation of Patients Affected by Any Type of Diabetes and Endocrine Disorders

The main objective of this retrospective and prospective observational register is to identify anthropometric, clinical, laboratory and/or instrumental markers of disease severity and activity in patients suffering from diabetes, endocrine-metabolic disorders, rare diseases in order to improve their diagnosis, monitoring and treatment processes. The Registry is monocentric, observational prospective and retrospective. No additional procedures to those of normal clinical practice are planned, and neither diagnostic approaches nor experimental drugs/prescriptions will be applied. The data under study (demographic, anthropometric, clinical and care characteristics) will be collected as part of outpatient visits of the Diabetes Outpatient Clinic or admission to Diabetes Day Hospital. In case of outpatients, the observation will start at the diagnosis or during the first outpatient visit and will end with the last outpatient visit performed within the total time foreseen for the duration of the study. The study will start once the regulatory authorizations are completed, and is expected to last at least 10 years with the possibility of extension

Detecting Liver Fibrosis in Patients At-risk

The project will establish a research cohort (called STELIR; STEatotisk Liver-risk In Rogaland) based on a biobank with an associated health register. The purpose is to collect, store and analyze biological material and clinical data from people at risk of steatotic liver disease (fatty liver disease). The research cohort will consist of individuals who agree to participate and will be followed over many years with planned examinations/tests at baseline, after 2 years, after 5 years and every 5 years thereafter. The STELIR cohort consists of individuals between 40 and 70 years of age who have one or more of the following risk factors: Obesity, type 2 diabetes or hazardous or harmful alcohol consumption. The biological material and clinical data collected will be stored and used for research on liver-related disease risk, diagnostics and treatment.

Impact of Delta Model of End Stage Liver Disease (MELD) in High MELD Liver Transplant Recipients

Liver transplantation (LT) represents an important curative option for end stage liver disease such as decompensated cirrhosis, which remains a major challenge for today's health care system. The Model for End-Stage Liver Disease (MELD) is a worldwide-established scoring system for the evaluation of the severity of liver disease in allocation processes. However, the interpretation of MELD in clinical practice, particularly with regard to prioritizing potential liver transplant recipients, has revealed some hazards. These include the adaptation of MELD based on patient's characteristics, e.g. the presence of hepatocellular carcinoma, kidney failure and cardiovascular disease. In addition, the remaining paucity of organ donors contributes to a rising number of transplantations of high MELD recipients. This leads to the risk of impaired outcomes, especially considering the interaction of additional donor and recipient risk factors, such as extended cold preservation, kidney function and warm ischemia. For a certain patient cohort living donation might represent a feasible approach as reported previously for high MELD patients. Overall, the interaction of donor and recipient characteristics on the outcomes after LT in high MELD patients remains a scarcely investigated field. Therefore, the identification of factors influencing patient's outcomes after orthotopic liver transplantation becomes increasingly important, especially in high MELD recipients.