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

• Conditions: Hepatocellular Carcinoma; Liver Cirrhosis; Portal Hypertension

• Registration Number: NCT06773260
• Lead Sponsor: Azienda Ospedaliero Universitaria Policlinico Modena

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.

Study Timeline

• Study Start: 2023-06-20
• Status Verified: 2024-06
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Study First Posted: 2025-01-14
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-22
• Primary Completion: 2025-06-15
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 150

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
: 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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (11)

UOC Gastroenterologia, Azienda Ospedaliero-Universitaria Policlinico Bari; 🇮🇹 Bari, Italy

UOC Gastroenterologia, IRCCS Policlinico Sant'Orsola, Università di Bologna; 🇮🇹 Bologna, Italy

UOC Semeiotica Medica, IRCCS Policlinico Sant'Orsola, Università di Bologna; 🇮🇹 Bologna, Italy

Programma Dipartimentale di I fascia, Malattie del Fegato e delle vie Biliari, Azienda Ospedaliera Universitaria - Federico II, Università degli Studi di Napoli Federico II, Napoli; 🇮🇹 Napoli, Italy

UOC Medicina interna, malattie epatobiliari e immunoallergologiche, IRCCS Policlinico Sant'Orsola, Università di Bologna; 🇮🇹 Bologna, Italy

UOC Gastroenterologia, Azienda Ospedaliera-Universitaria Policlinico di Modena; 🇮🇹 Modena, Italy

Azienda Ospedaliera; 🇮🇹 Novara, Italy

UOC Centro Malattie Apparato Digerente (CEMAD, IRCCS Policlinico Agostino Gemelli, Università Cattolica del Sacro Cuore,; 🇮🇹 Roma, Italy

Dipartimento delle Scienze Mediche,Chirurgiche e Neuroscienze,UNISIEN; 🇮🇹 Siena, Italy

USD Liver Unit, Azienda Ospedaliera Universitaria Integrata Verona; 🇮🇹 Verona, Italy

UOC Clinica Medica 5 - Unit of Internal Medicine and Hepatology, Azienda Ospedale Università Padova,; 🇮🇹 Padova, Italy