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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: roccomaurizio.zagari@unibo.it
• Phone: 0039 0512145704

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.