Hepatocellular CarcinomaELASTO-HCCNCT06773260
Liver and Spleen Stiffness to Predict the Presence of Esaphageal Varices in Cirrhotic With Advanced HCC
An observational study of Hepatocellular Carcinoma and Liver Cirrhosis, run by Azienda Ospedaliero Universitaria Policlinico Modena at 12 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Cirrhosis, Portal Hypertension
- What is being tested?
- Liver and Spleen stiffness measurement.
- How many people
- 150 participants
- Where
- 12 sitesItaly
- Study dates
- 20 Jun 2023to Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cirrhotic patients of any etiology with aHCC are scheduled to receive systemic treatment for HCC.
Who may be able to join
- 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.
Who cannot join
- Presence of splenic, mesenteric, or portal vein thrombosis.
- Previous placement of TIPS at the time of informed consent.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Italy12 sites
UOC Gastroenterologia, Azienda Ospedaliero-Universitaria Policlinico Bari
Bari, 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
Bologna, Italy
UOC Gastroenterologia, Azienda Ospedaliera-Universitaria Policlinico di Modena
Modena, 41126
UOC Gastroenterologia, Azienda Ospedaliera-Universitaria Policlinico di Modena
Modena
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
Naples, Italy
Azienda Ospedaliera
Novara, Italy
UOC Clinica Medica 5 - Unit of Internal Medicine and Hepatology, Azienda Ospedale Università Padova,
Padova, Italy
UOC Centro Malattie Apparato Digerente (CEMAD, IRCCS Policlinico Agostino Gemelli, Università Cattolica del Sacro Cuore,
Roma, Italy
Dipartimento delle Scienze Mediche,Chirurgiche e Neuroscienze,UNISIEN
Siena, Italy
USD Liver Unit, Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy
About this study
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
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
Read the 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.
- Being tested
- Liver and Spleen stiffness measurement.
- Keywords
- HCC, Liver stiffness, Spleen stiffness, Esophageal varices, Portal Hypertension
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Cirrhosis, Hypertension, Portal, Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Cirrhotic patients with advanced HCC | Cirrhotic patients with advanced HCC requiring systemic therapy will undergo upper endoscopy and measurement of liver and spleen stiffness. Receives: Diagnostic Test: Liver and Spleen stiffness measurement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
: 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
Measured: 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
According to Spleen stiffness measurement (SSM)/Baveno criteria, the number of upper endoscopies spared in patients without high-risk varices will be assessed.
Measured: from 2023 to 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start20 Jun 2023
- Primary completion15 Jun 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Policlinico Modena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANTONIO COLECCHIA, Azienda Ospedaliero Universitaria Policlinico Modena
- Investigators
- Alessandra Pivetti, MD, Study chair, Azienda Ospedaliera Universitaria Policlinico ModenaLuigi Colecchia, MD, Study chair, IRCCS Azienda Ospedaliero-Universitaria, BolognaElton Dajti, MD, Study chair, IRCCS Azienda Ospedaliero-Universitaria, Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773260
- Sponsor's protocol ID
- AOU Policlinico Modena
- Acronym
- ELASTO-HCC
- Status last verified
- Jun 2024
- First submitted
- 9 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06773260
- Acronym / sponsor ID
- ELASTO-HCC / AOU Policlinico Modena
- Keywords
- HCC, Liver stiffness, Spleen stiffness, Esophageal varices, Portal Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero Universitaria Policlinico ModenaUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cirrhotic patients with advanced HCC | – | Diagnostic Test: Liver and Spleen stiffness measurement.Cirrhotic patients with advanced HCC requiring systemic therapy will undergo upper endoscopy and measurement of liver and spleen stiffness. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cirrhotic patients of any etiology with aHCC are scheduled to receive systemic treatment for HCC.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Presence of splenic, mesenteric, or portal vein thrombosis.
- Previous placement of TIPS at the time of informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Cirrhotic patients with advanced HCC |
Primary outcome
: 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
1 secondary outcome
Number of upper digestive endoscopies spared and Varices Needing Treatment (VNT) missed according to SSM/Baveno criteria evaluated
Time frame: from 2023 to 2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandra Pivetti, MD study chair
Azienda Ospedaliera Universitaria Policlinico Modena
Luigi Colecchia, MD study chair
IRCCS Azienda Ospedaliero-Universitaria, Bologna
Elton Dajti, MD study chair
IRCCS Azienda Ospedaliero-Universitaria, Bologna
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Liver Cirrhosis, run by Azienda Ospedaliero Universitaria Policlinico Modena at 12 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: from 2023 to 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.