Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Cirrhosis | — | UNRESOLVED | — |
| Portal Hypertension | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liver and Spleen stiffness measurement. | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cirrhotic patients with advanced HCC
- description
- Cirrhotic patients with advanced HCC requiring systemic therapy will undergo upper endoscopy and measurement of liver and spleen stiffness.
- interventionNames
- Diagnostic Test: Liver and Spleen stiffness measurement.
Primary outcomes (1)
- 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
- description
- 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
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available