Portal Hypertension Related to CirrhosisNCT07122622
2D-shear Wave Spleen Elastography in Clinically Significant Portal Hypertension and High-risk Varices
An observational study of Portal Hypertension Related to Cirrhosis and Esophageal Varices, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The primary objective of this study is to evaluate the role of spleen shear wave elastography (SWE-SSM) for ruling in and ruling out clinically significant portal hypertension (CSPH) in patients with compensated advanced chronic liver disease (cACLD) and for ruling in and ruling out high-risk esophageal varices (HRV)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Portal Hypertension Related to Cirrhosis, Esophageal Varices
- How many people
- 450 participants
- Where
- 1 siteItaly
- Study dates
- 20 Aug 2025to 20 Aug 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referring to the Diagnostic and Interventional Ultrasound UOSD of the digestive system disease center of the University Hospital Policlinico A.Gemelli of Rome to undergo an ultrasound of the upper abdomen as part of their clinical pathway.
Who may be able to join
- Age greater than 18 years;
- SWE-LSM ≥9 kPa and/or TE-LSM ≥15 kPa;
Who cannot join
- Presence of transjugular intrahepatic porto-systemic shunt (TIPS);·
- Surgical absence of the spleen;
- Grade 3 ascites;
- History of variceal bleeding;
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Ultrasound diagnostic and interventional service "Policlinico A.Gemelli"
Roma, Italia, 00168
Garcovich, 0630155052, matteo.garcovich@policlinicogemelli.it
About this study
Official title: Role of 2D-shear Wave Spleen Elastography in Assessing Clinically Significant Portal Hypertension and High-risk Varices in Patients With Advanced Compensated Chronic Liver Disease.
The primary objective of this study is to evaluate the role of spleen shear wave elastography (SWE-SSM) for ruling in and ruling out clinically significant portal hypertension (CSPH) in patients with compensated advanced chronic liver disease (cACLD) and for ruling in and ruling out high-risk esophageal varices (HRV) in patients with CSPH. Secondary objectives of the study include the investigation of the correlation between SWE-SSM and portal pressure in a subgroup of patients undergoing hepatic venous pressure gradient (HVPG) measurement and between SWE-SSM and transient elastography (TE-SSM).
The values of SWE-SSM and SWE-LSM will be assessed during the ultrasound examination to which the patient will be subjected according to their care pathway. If inclusion criteria are met and informed consent is obtained, spleen elastography will be carried out (in addition to the routine SWE-LSM planned in clinical practice). Spleen elastography will not alter the standard ultrasound examination but represents a non-invasive diagnostic addition.
There will be no treatment or experimental intervention that will modify the patient's condition or directly influence their clinical course. The aim is to collect data based on clinical observations without altering the treatment or the natural course of the disease.
- Medical subject headings
- Esophageal and Gastric Varices
What is being measured
The primary outcome is the main question the study is designed to answer.
CSPH
The following data will be collected:
- Shear Wave Elastography of the spleen (SWE-SSM): continuous variable, expression of splenic stiffness, measured in kPa;
- Shear Wave Elastography of the liver (SWE-LSM): continuous variable, expression of hepatic stiffness, measured in kPa;
- Transient Elastography of the spleen (TE-SSM): continuous variable, expression of splenic stiffness, measured in kPa;
- Transient Elastography of the liver (TE-LSM): continuous variable, expression of hepatic stiffness, measured in kPa;
- Bipolar diameter of the spleen: measured in centimeters
- Ascites yes/no;
- Collateral circulation yes/no;
- Encephalopathy yes/no;
- Non selective beta-blockers yes/no;
- Hepatic Venous Pressure Gradient (HVPG): continuous variable, portosystemic pressure gradient, measured in mmHg.
Measured: 2 years
Secondary outcomes (1)
HRV
The following data will be collected:
- Shear Wave Elastography of the spleen (SWE-SSM): continuous variable, expression of splenic stiffness, measured in kPa;
- Shear Wave Elastography of the liver (SWE-LSM): continuous variable, expression of hepatic stiffness, measured in kPa;
- Transient Elastography of the spleen (TE-SSM): continuous variable, expression of splenic stiffness, measured in kPa;
- Transient Elastography of the liver (TE-LSM): continuous variable, expression of hepatic stiffness, measured in kPa;
- Bipolar diameter of the spleen: measured in centimeters
- Endoscopic data: esophageal varices classified as F1, F2, F3 and with/without red spots.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start20 Aug 2025
- Primary completion20 Aug 2027 (estimated)
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal Hypertension Related to CirrhosisStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Garcovich Matteo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122622
- Sponsor's protocol ID
- 7514
- Status last verified
- Nov 2025
- First submitted
- 2 Jun 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of 2D-shear Wave Spleen Elastography in Assessing Clinically Significant Portal Hypertension and High-risk Varices in Patients With Advanced Compensated Chronic Liver Disease.
- ClinicalTrials.gov ID
- NCT07122622
- Acronym / sponsor ID
- 7514
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 20 Aug 2027 (estimated)
- Study completion
- 20 Aug 2027 (estimated)
- First posted
- 14 Aug 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.
The primary objective of this study is to evaluate the role of spleen shear wave elastography (SWE-SSM) for ruling in and ruling out clinically significant portal hypertension (CSPH) in patients with compensated advanced chronic liver disease (cACLD) and for ruling in and ruling out high-risk esophageal varices (HRV) in patients with CSPH. Secondary objectives of the study include the investigation of the correlation between SWE-SSM and portal pressure in a subgroup of patients undergoing hepatic venous pressure gradient (HVPG) measurement and between SWE-SSM and transient elastography (TE-SSM).
The values of SWE-SSM and SWE-LSM will be assessed during the ultrasound examination to which the patient will be subjected according to their care pathway. If inclusion criteria are met and informed consent is obtained, spleen elastography will be carried out (in addition to the routine SWE-LSM planned in clinical practice). Spleen elastography will not alter the standard ultrasound examination but represents a non-invasive diagnostic addition.
There will be no treatment or experimental intervention that will modify the patient's condition or directly influence their clinical course. The aim is to collect data based on clinical observations without altering the treatment or the natural course of the disease.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referring to the Diagnostic and Interventional Ultrasound UOSD of the digestive system disease center of the University Hospital Policlinico A.Gemelli of Rome to undergo an ultrasound of the upper abdomen as part of their clinical pathway.
Key inclusion criteria (2 listed)
- Age greater than 18 years;
- SWE-LSM ≥9 kPa and/or TE-LSM ≥15 kPa;
Key exclusion criteria (5 listed)
- Presence of transjugular intrahepatic porto-systemic shunt (TIPS);·
- Surgical absence of the spleen;
- Grade 3 ascites;
- History of variceal bleeding;
- Refusal to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CSPH
Time frame: 2 years
The following data will be collected: * Shear Wave Elastography of the spleen (SWE-SSM): continuous variable, expression of splenic stiffness, measured in kPa; * Shear Wave Elastography of the liver (SWE-LSM): continuous variable, expression of hepatic stiffness, measured in kPa; * Transient Elastography of the spleen (TE-SSM): continuous variable, expression of splenic stiffness, measured in kPa; * Transient Elastography of the liver (TE-LSM): continuous variable, expression of hepatic stiffness, measured in kPa; * Bipolar diameter of the spleen: measured in centimeters * Ascites yes/no; * Collateral circulation yes/no; * Encephalopathy yes/no; * Non selective beta-blockers yes/no; * Hepatic Venous Pressure Gradient (HVPG): continuous variable, portosystemic pressure gradient, measured in mmHg.
1 secondary outcome
HRV
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Portal Hypertension Related to Cirrhosis and Esophageal Varices, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matteo Garcovich doctor (0039 0630156018, matteo.garcovich@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSPH (time frame: 2 years). 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 25 Nov 2025.