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NCT Number: NCT06777017

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Rocco Maurizio Zagari, MD

CONTACT

[email protected]

00390512145734

Rozzo Maurizio Zagari, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Association between hepatic and splenic elastography values and the risk of HCC recurrence after treatment with RFA

    Time frame: 12 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Rocco Maurizio Zagari, MD

CONTACT

[email protected]

0039 0512145704

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Acronym: ELASTORFA

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 15, 2025
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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