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

NCT06777017 | Recruiting

• 1 other identifier: ELASTORFA
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

HCC - Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Rocco Maurizio Zagari, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rocco Maurizio Zagari, MD

CONTACT

0039 0512145704; roccomaurizio.zagari@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 15, 2025
• Study Start: April 22, 2022
• Primary Completion: May 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 15, 2025

Record last verified: 2024-12

Locations

IT (1)