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

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

Study Overview

• Status: Recruiting
• Conditions: HCC - Hepatocellular Carcinoma

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Rocco Maurizio Zagari, MD; Phone Number: 0039 0512145704; Email: roccomaurizio.zagari@unibo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero - Universitaria di Bologna
    • Contact: Rocco Maurizio Zagari, MD; Phone Number: 00390512145734; Email: roccomaurizio.zagari@unibo.it
    • Principal Investigator: Rozzo Maurizio Zagari, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Hepatopathic patients with HCC who are candidates for treatment with RFA and who are admitted to the coordinating center "U.O.C. of Gastroenterology and Digestive Endoscopy" of the IRCSS University Hospital Company, Policlinico di S.Orsola and to the Participating Center "U.O. of Gastroenterology", Integrated University Hospital of Modena are eligible to enter the study. Patients who meet the inclusion criteria will be enrolled in the study. Patients may be enrolled during treatment-preventive outpatient visits, during the elastographic examination or at the time of scheduled admission to the participating U.O. for the execution of the treatment

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between hepatic and splenic elastography values and the risk of HCC recurrence after treatment with RFA	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	12 months

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Rocco Maurizio Zagari, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2022
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 10, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Disease Attributes; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Recurrence; Carcinoma, Hepatocellular
• Other Study ID Numbers: ELASTORFA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No