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

NCT ID: NCT06773260

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-20
• Study Completion Date: 2025-10-31

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.

Conditions

Hepatocellular Carcinoma; Liver Cirrhosis; Portal Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cirrhotic patients with advanced HCC

Cirrhotic patients with advanced HCC requiring systemic therapy will undergo upper endoscopy and measurement of liver and spleen stiffness.

Liver and Spleen stiffness measurement.

Intervention Type: DIAGNOSTIC_TEST

The use of spleen stiffness measurement to reduce unnecessary upper digestive endoscopies has never been evaluated in this patient setting.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero Universitaria Policlinico Modena

OTHER

Sponsor Role: lead

Responsible Party

ANTONIO COLECCHIA

Prof of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alessandra Pivetti, MD

Role: STUDY_CHAIR

Azienda Ospedaliera Universitaria Policlinico Modena

Luigi Colecchia, MD

Role: STUDY_CHAIR

IRCCS Azienda Ospedaliero-Universitaria, Bologna

Elton Dajti, MD

Role: STUDY_CHAIR

IRCCS Azienda Ospedaliero-Universitaria, Bologna

Locations

UOC Gastroenterologia, Azienda Ospedaliero-Universitaria Policlinico Bari

Bari, Italy, Italy

UOC Gastroenterologia, IRCCS Policlinico Sant'Orsola, Università di Bologna

Bologna, Italy, Italy

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

Bologna, Italy, Italy

UOC Semeiotica Medica, IRCCS Policlinico Sant'Orsola, Università di Bologna

Bologna, Italy, 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, Italy

Azienda Ospedaliera

Novara, Italy, Italy

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

Padua, Italy, Italy

UOC Centro Malattie Apparato Digerente (CEMAD, IRCCS Policlinico Agostino Gemelli, Università Cattolica del Sacro Cuore,

Roma, Italy, Italy

Dipartimento delle Scienze Mediche,Chirurgiche e Neuroscienze,UNISIEN

Siena, Italy, Italy

USD Liver Unit, Azienda Ospedaliera Universitaria Integrata Verona

Verona, Italy, Italy

UOC Gastroenterologia, Azienda Ospedaliera-Universitaria Policlinico di Modena

Modena, , Italy

UOC Gastroenterologia, Azienda Ospedaliera-Universitaria Policlinico di Modena

Modena, , Italy

Countries

Italy

Other Identifiers

AOU Policlinico Modena

Identifier Type: -

Identifier Source: org_study_id