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

January 20, 2025 updated by: ANTONIO COLECCHIA, Azienda Ospedaliero Universitaria Policlinico Modena

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

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy
        • UOC Gastroenterologia, Azienda Ospedaliero-Universitaria Policlinico Bari
      • Bologna, Italy
        • UOC Gastroenterologia, IRCCS Policlinico Sant'Orsola, Università di Bologna
      • Bologna, Italy
        • UOC Medicina interna, malattie epatobiliari e immunoallergologiche, IRCCS Policlinico Sant'Orsola, Università di Bologna
      • Bologna, Italy
        • UOC Semeiotica Medica, IRCCS Policlinico Sant'Orsola, Università di Bologna
      • Modena, Italy, 41126
        • UOC Gastroenterologia, Azienda Ospedaliera-Universitaria Policlinico di Modena
      • Modena, Italy
        • UOC Gastroenterologia, Azienda Ospedaliera-Universitaria Policlinico di Modena
      • Napoli, 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
      • Novara, Italy
        • Azienda Ospedaliera
      • Padova, Italy
        • UOC Clinica Medica 5 - Unit of Internal Medicine and Hepatology, Azienda Ospedale Università Padova,
      • Roma, Italy
        • UOC Centro Malattie Apparato Digerente (CEMAD, IRCCS Policlinico Agostino Gemelli, Università Cattolica del Sacro Cuore,
      • Siena, Italy
        • Dipartimento delle Scienze Mediche,Chirurgiche e Neuroscienze,UNISIEN
      • Verona, Italy
        • USD Liver Unit, Azienda Ospedaliera Universitaria Integrata Verona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Cirrhotic patients of any etiology with aHCC are scheduled to receive systemic treatment for HCC.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cirrhotic patients with advanced HCC
Cirrhotic patients with advanced HCC requiring systemic therapy will undergo upper endoscopy and measurement of liver and spleen stiffness.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
: 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.
Time Frame: 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
from 2023 to 2025

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of upper digestive endoscopies spared and Varices Needing Treatment (VNT) missed according to SSM/Baveno criteria evaluated
Time Frame: 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.
from 2023 to 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero Universitaria Policlinico Modena

Investigators

  • Study Chair: Alessandra Pivetti, MD, Azienda Ospedaliera Universitaria Policlinico Modena
  • Study Chair: Luigi Colecchia, MD, IRCCS Azienda Ospedaliero-Universitaria, Bologna
  • Study Chair: Elton Dajti, MD, IRCCS Azienda Ospedaliero-Universitaria, Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2023

Primary Completion (Estimated)

June 15, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 9, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 20, 2025

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOU Policlinico Modena

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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