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

NCT06773260 | Enrolling By Invitation

• 1 other identifier: AOU Policlinico Modena
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 12

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

Conditions

Hepatocellular Carcinoma; Liver Cirrhosis; Portal Hypertension

Keywords

HCC; Liver stiffness; Spleen stiffness; Esophageal varices; Portal Hypertension

Outcome Measures

Primary Outcomes (1)

• : 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.

  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 Outcomes (1)

• Number of upper digestive endoscopies spared and Varices Needing Treatment (VNT) missed according to SSM/Baveno criteria evaluated

  from 2023 to 2025

Study Arms (1)

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.

Interventions

Liver and Spleen stiffness measurement. DIAGNOSTIC_TEST

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

Cirrhotic patients with advanced HCC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Presence of splenic, mesenteric, or portal vein thrombosis.
• Previous placement of TIPS at the time of informed consent.

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Policlinico Modena: lead

Study Sites (12)

UOC Gastroenterologia, Azienda Ospedaliero-Universitaria Policlinico Bari

Bari, Italy, Italy

Location

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

Bologna, Italy, Italy

Location

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

Bologna, Italy, Italy

Location

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

Bologna, Italy, Italy

Location

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

Location

Azienda Ospedaliera

Novara, Italy, Italy

Location

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

Padua, Italy, Italy

Location

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

Roma, Italy, Italy

Location

Dipartimento delle Scienze Mediche,Chirurgiche e Neuroscienze,UNISIEN

Siena, Italy, Italy

Location

USD Liver Unit, Azienda Ospedaliera Universitaria Integrata Verona

Verona, Italy, Italy

Location

UOC Gastroenterologia, Azienda Ospedaliera-Universitaria Policlinico di Modena

Modena, 41126, Italy

Location

UOC Gastroenterologia, Azienda Ospedaliera-Universitaria Policlinico di Modena

Modena, Italy

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Cirrhosis; Hypertension, Portal; Esophageal and Gastric Varices

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• 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 CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof of Gastroenterology

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 14, 2025
• Study Start: June 20, 2023
• Primary Completion: June 15, 2025
• Study Completion: October 1, 2025
• Last Updated: January 22, 2025

Record last verified: 2024-06

Locations

IT (12)