Can Hepatic-splenic Elastography Predict the Risk of Hepatocellular Recurrence After Radiofrequency Ablation?

NCT ID: NCT06777017

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-22
• Study Completion Date: 2025-12-31

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.

Conditions

HCC - Hepatocellular Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rocco Maurizio Zagari, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Rocco Maurizio Zagari, MD

Role: CONTACT

roccomaurizio.zagari@unibo.it

0039 0512145704

Facility Contacts

Rocco Maurizio Zagari, MD

Role: primary

roccomaurizio.zagari@unibo.it

00390512145734

Other Identifiers

ELASTORFA

Identifier Type: -

Identifier Source: org_study_id