Assessing elastography's role in predicting liver cancer recurrence after treatment

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

This study is testing if a non-invasive method called elastography can help predict if liver cancer will come back after treatment in patients who have undergone radiofrequency ablation.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna (other)
• Locations: 1 site (Bologna)
• Trial ID: NCT06777017 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the relationship between hepatic and splenic elastography values and the risk of hepatocellular carcinoma (HCC) recurrence following radiofrequency ablation (RFA) treatment. The primary objective is to determine if these elastography values can predict recurrence, while secondary objectives include assessing their association with overall survival, HCC-related survival, and the risk of liver decompensation post-treatment. The study will involve hepatopathic patients diagnosed with HCC who are candidates for RFA, utilizing non-invasive methods for elastography assessment. Participants will be recruited from specific gastroenterology centers in Bologna, Italy.

Who should consider this trial

Good fit: Ideal candidates include adults with chronic liver disease and a clinical diagnosis of HCC who are eligible for RFA treatment.

Not a fit: Patients under 18 years old or those with other severe liver conditions or advanced diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a non-invasive method to predict the risk of HCC recurrence, potentially improving patient management and outcomes.

How similar studies have performed: While the approach of using elastography in this context is promising, it remains to be seen if similar studies have demonstrated success, as this specific association is not widely tested.

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).

Where this trial is running

Bologna

• IRCCS Azienda Ospedaliero - Universitaria di Bologna — Bologna, Italy (RECRUITING)

Study contacts

• Principal investigator: Rocco Maurizio Zagari, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Study coordinator: Rocco Maurizio Zagari, MD

Conditions: HCC - Hepatocellular Carcinoma