Project title
Idiopathic Non-Cirrhotic portal hypertension: regIonal registry for improving the iDentification of nEw non-invasive diagnostic tools
Hipertensiunea portala idiopatica: Registrul Regional pentru identificarea de noi metode neinvazive de diagnostic
Project Acronym INCIDEr
Summary
Idiopathic portal hypertension (IPH) and non-cirrhotic portal vein thrombosis (PVT) are the two most frequent causes of non-cirrhotic portal hypertension (PH). If the PVT’s diagnosis is easy, IPH can only be diagnosed invasively by liver biopsy and after the exclusion of other causes of PH, such as cirrhosis. Dynamic Contrast Enhanced Ultrasound (D-CEUS) and Real-Time Shear-Wave Elastography (RT-SWE) proved to be good diagnostic tools for PH.
The study’s objective is to validate new non-invasive diagnostic methods for IPH and to test their ability to differentiate IPH from cirrhosis. Another objective is to develop a Regional Registry for IPH patients.
Methodology
We will include 25-30 patients with IPH and, as control groups, 30 patients with PVT and 50 patients with cirrhosis evaluated at Regional Institute of Gastroenterology and Hepatology “Prof. Dr. Octavian Fodor” Cluj-Napoca, after signing the informed consent. D-CEUS examination of the liver and RT- SWE of the liver and spleen using Aixplorer US system (SuperSonic Image S.A., Aix-en-Provence, France) will be performed for all patients. D-CEUS will calculate the regional hepatic reperfusion rates that should be completely different in IPH and cirrhosis. RT-SWE should also differentiate well between the two conditions. Non-targeted and targeted metabolomic analysis will be conducted in order to find a new metabolic profile associated with IPH and to test its’ discriminative performances between IPH and cirrhosis. An IPH patient registry platform will be created using Research Electronic Data Capture (REDCap®). This registry will contain all demographic, clinical and follow-up data of IPH patients. Biological samples of these patients will be collected and securely stored into a biobank.
The registry and the biobank will be open to participation for other Romanian centers and will provide opportunities for further international collaborations in multi-centric studies.