Liver and Spleen Stiffness to Predict the Presence of Esaphageal Varices in Cirrhotic with Advanced HCC (ELASTO-HCC)

Azienda Ospedaliero Universitaria Policlinico Modena

Status

Invitation-only

Conditions

Portal Hypertension

Liver Cirrhosis

Hepatocellular Carcinoma

Treatments

Diagnostic Test: Liver and Spleen stiffness measurement.

Study type

Observational

Funder types

Other

Identifiers

NCT06773260

AOU Policlinico Modena

Details and patient eligibility

About

Elasto-HCC is a prospective, uncontrolled, multicenter observational study involving several hepatology centers in Italy. Patients with liver cirrhosis and advanced hepatocellular carcinoma (HCC) who will need to undergo systemic therapy will be enrolled. Patients in the first phase will undergo measurement of liver and spleen stiffness and upper endoscopic evaluation and will subsequently be followed for 12 months

Full description

Hepatocellular carcinoma (HCC) and clinically significant portal hypertension (CSPH) frequently coexist, affecting cirrhotic individuals' prognosis. Recently it has been confirmed that in cirrhotic patients with favorable Baveno VI consensus (platelets>150000/mm3 and liver stiffness measurement (LSM<20 kPa) or combined model based on spleen stiffness, endoscopic screening for varices could be avoided. The Portal Hypertension (PH)-related complications in all patients should be avoided and well managed, especially if they have advanced HCC (aHCC) at diagnosis. However, unlike patients without HCC, endoscopy is recommended for those who undergo systemic therapy, even if compatible with favorable Baveno VI consensus . The reasons for this indication derive from the consideration that the presence of HCC could influence the measurement of LSM and platelet count.

To date, in cirrhotic patients without HCC, according to Baveno VII consensus and the last EASL guidelines for non-invasive tests (NITs), besides LSM, Spleen Stiffness Measurement (SSM) is now considered the most accurate NITs for assessing portal hypertension and predicting the presence of esophageal varices (EVs) and varices needing treatment (VNT).

To date, no studies have evaluated the accuracy of NITs (LSM/SSM) on patients with advanced HCC (aHCC) who should undergo systemic therapy.

The study aims to assess the performance of SSM to rule out VNT in patients with aHCC who undergo systemic therapy.

Each center will prospectively collect data according to an electronic e-CFR on REDCap (Research Electronic Data Capture) system, a web application designed to support data capture for research studies in a secure manner.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age > 18 yrs;
Cirrhotic patients of any etiology with aHCC scheduled to receive any line of systemic treatment for HCC;
Patients are willing and able to give informed consent.

Exclusion criteria