Clinical trial NCT06773260: Liver and Spleen Stiffness to Predict the Presence of Esaphageal Varices in Cirrhotic With Advanced HCC
Official title: 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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hepatocellular Carcinoma
Liver Cirrhosis
Portal Hypertension
Keywords: HCC
Liver stiffness
Spleen stiffness
Esophageal varices
Portal Hypertension
Lead sponsor: Azienda Ospedaliero Universitaria Policlinico Modena
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cirrhotic patients of any etiology with aHCC are scheduled to receive systemic treatment for HCC.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: : 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.
timeFrame: from 2023 to 2025
Secondary outcomes:
measure: Number of upper digestive endoscopies spared and Varices Needing Treatment (VNT) missed according to SSM/Baveno criteria evaluated
timeFrame: from 2023 to 2025
Other outcomes:
Locations:
city: Bari
country: Italy
facility: UOC Gastroenterologia, Azienda Ospedaliero-Universitaria Policlinico Bari
city: Bologna
country: Italy
facility: UOC Gastroenterologia, IRCCS Policlinico Sant'Orsola, Università di Bologna
city: Bologna
country: Italy
facility: UOC Medicina interna, malattie epatobiliari e immunoallergologiche, IRCCS Policlinico Sant'Orsola, Università di Bologna
city: Bologna
country: Italy
facility: UOC Semeiotica Medica, IRCCS Policlinico Sant'Orsola, Università di Bologna
city: Modena
country: Italy
facility: UOC Gastroenterologia, Azienda Ospedaliera-Universitaria Policlinico di Modena
city: Modena
country: Italy
facility: UOC Gastroenterologia, Azienda Ospedaliera-Universitaria Policlinico di Modena
city: Napoli
country: Italy
facility: 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
city: Novara
country: Italy
facility: Azienda Ospedaliera
city: Padova
country: Italy
facility: UOC Clinica Medica 5 - Unit of Internal Medicine and Hepatology, Azienda Ospedale Università Padova,
city: Roma
country: Italy
facility: UOC Centro Malattie Apparato Digerente (CEMAD, IRCCS Policlinico Agostino Gemelli, Università Cattolica del Sacro Cuore,
city: Siena
country: Italy
facility: Dipartimento delle Scienze Mediche,Chirurgiche e Neuroscienze,UNISIEN
city: Verona
country: Italy
facility: USD Liver Unit, Azienda Ospedaliera Universitaria Integrata Verona
Study officials:
affiliation: Azienda Ospedaliera Universitaria Policlinico Modena
name: Alessandra Pivetti, MD
role: STUDY_CHAIR
affiliation: IRCCS Azienda Ospedaliero-Universitaria, Bologna
name: Luigi Colecchia, MD
role: STUDY_CHAIR
affiliation: IRCCS Azienda Ospedaliero-Universitaria, Bologna
name: Elton Dajti, MD
role: STUDY_CHAIR
References: