NCT06773260

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

Assessment of Liver and Spleen Stiffness Measurement (LSM/SSM) Accuracy in Predicting the Presence of Oesophageal Varices Needing Treatment in Cirrhotic Patients With Advanced Hepatocellular Carcinoma (HCC) Who Undergo Systemic Therapy

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Azienda Ospedaliero Universitaria Policlinico Modena · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma
• Liver Cirrhosis
• Portal Hypertension

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Liver and Spleen stiffness measurement.	The use of spleen stiffness measurement to reduce unnecessary upper digestive endoscopies has never been evaluated in this patient setting.

Timeline

• Start date: 2023-06-20
• Primary completion: 2025-06-15
• Completion: 2025-10-01
• First posted: 2025-01-14
• Last updated: 2025-01-22

Locations

12 sites across 1 country: Italy