Clinical trial NCT06777017: Can Hepatic-splenic Elastography Predict the Risk of Hepatocellular Recurrence After Radiofrequency Ablation?
Official title: Can Hepatic-splenic Elastography Predict the Risk of Hepatocellular Recurrence After Radiofrequency Ablation?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HCC - Hepatocellular Carcinoma
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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).

Primary outcomes:
measure: Association between hepatic and splenic elastography values and the risk of HCC recurrence after treatment with RFA
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero - Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Rocco Maurizio Zagari, MD
role: PRINCIPAL_INVESTIGATOR
References: