Hepatocellular Carcinoma, Liver Cirrhosis, Portal Hypertension
Conditions
Keywords
HCC, Liver stiffness, Spleen stiffness, Esophageal varices, Portal Hypertension
Brief summary
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
Detailed 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.
Interventions
DIAGNOSTIC_TESTLiver and Spleen stiffness measurement.
The use of spleen stiffness measurement to reduce unnecessary upper digestive endoscopies has never been evaluated in this patient setting.
Sponsors
Azienda Ospedaliero Universitaria Policlinico Modena
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
* Presence of splenic, mesenteric, or portal vein thrombosis. * Previous placement of TIPS at the time of informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| : to evaluate the accuracy of Liver and Spleen stiffness in predicting the presence of high-risk EV needing treatment (VNT) in cirrhotic patients with aHCC who undergo systemic therapy. | from 2023 to 2025 | The patients at enrolment will be undergoing Upper endoscopy to assess the presence of esophageal or gastric varices and abdominal ultrasound (US) and contextual Liver and Spleen stiffness (LSM and SSM) with both Transient Elastography (FibroScan, Echosens) and a 2D-Shear-Wave Elastosonography to assess the Portal Hypertension (PH) degree; furthermore , biochemical analyses including platelet count (10\^9/mm3), will also be performed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of upper digestive endoscopies spared and Varices Needing Treatment (VNT) missed according to SSM/Baveno criteria evaluated | from 2023 to 2025 | According to Spleen stiffness measurement (SSM)/Baveno criteria, the number of upper endoscopies spared in patients without high-risk varices will be assessed. |
Countries
Italy
Outcome results
None listed