HCC - Hepatocellular Carcinoma
Conditions
Brief summary
The study aims to assess whether there is an association between hepatic and splenic elastography values and the risk of HCC recurrence after treatment with RFA
Detailed description
The primary objective of the study will be to assess whether there is an association between hepatic and splenic elastography values and the risk of HCC recurrence after treatment with RFA. Secondary objectives, however, will be to test whether hepatic and splenic elastography values have an association with overall and HCC-related survival and with the risk of decompensation after treatment with RFA; further secondary objective will be to evaluate the association between non-invasive biochemical tests and the risk of HCC recurrence after treatment with RFA. The population will consist of hepatopathic patients with HCC who are candidates for treatment with RFA and who are referred to the coordinating center U.O.C. of Gastroenterology and Digestive Endoscopy of IRCSS Azienda Ospedaliero-Universitaria, Policlinico di S.Orsola and the Participating Center U.O. of Gastroenterology, Azienda Ospedaliero-Universitaria Integrata di Modena.
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical-instrumental diagnosis of chronic liver disease. * Indication for treatment of HCC with RFA using the Barcelona Clinic Liver Cancer (BCLC staging system) classification system19; * Performing hepatic or splenic elastography by transient method with Fibroscan® (Echosens, Paris, France) or ARFI method (ACUSON Sequoia Siemens). * Signature of informed consent
Exclusion criteria
* Age \< 18 years; * Diagnosis of hepatocholangiocarcinoma or other hepatic focal lesions other than hepatocellular carcinoma; * Previous history of liver transplantation (OLT) and/or liver resection for HCC in the previous two years; * Liver disease in decompensation (Child-Pugh C) at the time of informed consent or within three months prior to enrollment; * Patients with other severe and advanced diseases that may affect short-term mortality (e.g. further non-remission neoplasms, heart failure \>NYHA III, chronic renal failure in dialysis, pulmonary diseases dependent on home oxygen therapy).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Association between hepatic and splenic elastography values and the risk of HCC recurrence after treatment with RFA | 12 months | The primary objective of the study will be to assess whether there is an association between hepatic and splenic elastography values and the risk of HCC recurrence after treatment with RFA |
Countries
Italy
Contacts
Primary ContactRocco Maurizio Zagari, MD
Outcome results
None listed