Prehepatic Portal HypertensionNCT07782554
EUS-Guided Portal Pressure Gradient Measurement in Prehepatic Portal Hypertension
An observational study of Prehepatic Portal Hypertension, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Portal hypertension caused by prehepatic vascular obstruction, such as portal vein thrombosis or portal vein tumor thrombosis, represents a unique hemodynamic condition in which conventional hepatic venous pressure gradient (HVPG) measurement may not accurately reflect portal venous pressure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Prehepatic Portal Hypertension
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 30 Jun 2026
- 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: This study included patients with liver cirrhosis complicated by prehepatic portal hypertension due to portal venous obstruction. All patients had esophagogastric varices and underwent abdominal computed tomography, ultrasound elastography, hepatic venous pressure gradient measurement, and endoscopic ultrasound-guided portal pressure gradient measurement. The study evaluated the relationship between portal pressure measurements and clinical characteristics, including liver disease etiology, liver function grade, gastrointestinal bleeding, and hepatic encephalopathy.
Who may be able to join
- Age ≥18 years; Confirmed diagnosis of cirrhosis complicated by portal venous obstructionbased on clinical, laboratory, and imaging findings; Written informed consent;
Who cannot join
- Severe coagulopathy, defined as an International Normalized Ratio (INR) >1.5; Severe thrombocytopenia, defined as a platelet count <30 × 10^9/L; Severe systemic comorbidities, including active sepsis, decompensated heart failure, or severe chronic obstructive pulmonary disease; Psychiatric or cognitive disorders that preclude cooperation with study procedures; Refusal to undergo hepatic venous pressure gradient (HVPG) or endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement;
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
About this study
Official title: Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement in Patients With Prehepatic Portal Hypertension: A Retrospective Observational Study
Portal hypertension caused by prehepatic vascular obstruction, such as portal vein thrombosis or portal vein tumor thrombosis, represents a unique hemodynamic condition in which conventional hepatic venous pressure gradient (HVPG) measurement may not accurately reflect portal venous pressure. Endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement provides a direct approach for assessing portal hemodynamics.
This retrospective observational study included patients with cirrhosis and esophagogastric varices complicated by portal vein thrombosis or portal vein tumor thrombosis. All patients underwent abdominal computed tomography to confirm the presence of portal vein obstruction, liver stiffness measurement by ultrasound elastography, HVPG measurement, and EUS-PPG measurement. The study aims to evaluate the relationship between EUS-PPG and HVPG and to explore the associations between portal pressure measurements and clinical characteristics, including underlying liver disease etiology, liver function grade, sex, gastrointestinal bleeding, and hepatic encephalopathy.
- Conditions
- Prehepatic Portal Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between EUS-Guided Portal Pressure Gradient and Hepatic Venous Pressure Gradient
The correlation between portal pressure gradient measured by endoscopic ultrasound-guided direct portal pressure measurement (EUS-PPG) and hepatic venous pressure gradient (HVPG) will be assessed using paired measurements obtained during the same procedural session. Both EUS-PPG and HVPG are measured in mmHg. The strength of the correlation will be quantified using a correlation coefficient.
Measured: Periprocedural
Secondary outcomes (3)
Difference Between Distal-to-Obstruction and Proximal-to-Obstruction EUS-Guided Portal Pressure Gradients
The difference between distal-to-obstruction portal pressure gradient (dis-Obs PPG) and proximal-to-obstruction portal pressure gradient (pro-Obs PPG), measured by endoscopic ultrasound-guided direct portal pressure measurement, will be assessed using paired measurements obtained during the same procedural session. Both pressure gradients are measured in mmHg.
Measured: Periprocedural
Difference Between Distal-to-Obstruction EUS-Guided Portal Pressure Gradient and Hepatic Venous Pressure Gradient
The difference between distal-to-obstruction portal pressure gradient (dis-Obs PPG), measured by endoscopic ultrasound-guided direct portal pressure measurement, and hepatic venous pressure gradient (HVPG), measured by standard hepatic venous catheterization, will be assessed using paired measurements obtained during the same procedural session. Both pressure gradients are measured in mmHg.
Measured: Periprocedural
Difference in Distal-to-Obstruction EUS-Guided Portal Pressure Gradient Between Patients With and Without Variceal Bleeding
Distal-to-obstruction portal pressure gradient (dis-Obs PPG), measured by endoscopic ultrasound-guided direct portal pressure measurement and expressed in mmHg, will be compared between patients with and without variceal bleeding related to portal hypertension.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Mar 2025
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prehepatic Portal HypertensionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782554
- Sponsor's protocol ID
- 2025-0821
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement in Patients With Prehepatic Portal Hypertension: A Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT07782554
- Acronym / sponsor ID
- 2025-0821
- Conditions
- Prehepatic Portal Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 24 Aug 2026 (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.
Portal hypertension caused by prehepatic vascular obstruction, such as portal vein thrombosis or portal vein tumor thrombosis, represents a unique hemodynamic condition in which conventional hepatic venous pressure gradient (HVPG) measurement may not accurately reflect portal venous pressure. Endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement provides a direct approach for assessing portal hemodynamics.
This retrospective observational study included patients with cirrhosis and esophagogastric varices complicated by portal vein thrombosis or portal vein tumor thrombosis. All patients underwent abdominal computed tomography to confirm the presence of portal vein obstruction, liver stiffness measurement by ultrasound elastography, HVPG measurement, and EUS-PPG measurement. The study aims to evaluate the relationship between EUS-PPG and HVPG and to explore the associations between portal pressure measurements and clinical characteristics, including underlying liver disease etiology, liver function grade, sex, gastrointestinal bleeding, and hepatic encephalopathy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study included patients with liver cirrhosis complicated by prehepatic portal hypertension due to portal venous obstruction. All patients had esophagogastric varices and underwent abdominal computed tomography, ultrasound elastography, hepatic venous pressure gradient measurement, and endoscopic ultrasound-guided portal pressure gradient measurement. The study evaluated the relationship between portal pressure measurements and clinical characteristics, including liver disease etiology, liver function grade, gastrointestinal bleeding, and hepatic encephalopathy.
Key inclusion criteria (1 listed)
- Age ≥18 years; Confirmed diagnosis of cirrhosis complicated by portal venous obstructionbased on clinical, laboratory, and imaging findings; Written informed consent;
Key exclusion criteria (1 listed)
- Severe coagulopathy, defined as an International Normalized Ratio (INR) >1.5; Severe thrombocytopenia, defined as a platelet count <30 × 10^9/L; Severe systemic comorbidities, including active sepsis, decompensated heart failure, or severe chronic obstructive pulmonary disease; Psychiatric or cognitive disorders that preclude cooperation with study procedures; Refusal to undergo hepatic venous pressure gradient (HVPG) or endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement;
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
Correlation Between EUS-Guided Portal Pressure Gradient and Hepatic Venous Pressure Gradient
Time frame: Periprocedural
The correlation between portal pressure gradient measured by endoscopic ultrasound-guided direct portal pressure measurement (EUS-PPG) and hepatic venous pressure gradient (HVPG) will be assessed using paired measurements obtained during the same procedural session. Both EUS-PPG and HVPG are measured in mmHg. The strength of the correlation will be quantified using a correlation coefficient.
3 secondary outcomes
Difference Between Distal-to-Obstruction and Proximal-to-Obstruction EUS-Guided Portal Pressure Gradients
Time frame: Periprocedural
Difference Between Distal-to-Obstruction EUS-Guided Portal Pressure Gradient and Hepatic Venous Pressure Gradient
Time frame: Periprocedural
Difference in Distal-to-Obstruction EUS-Guided Portal Pressure Gradient Between Patients With and Without Variceal Bleeding
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Prehepatic Portal Hypertension, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Aug 2026. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation Between EUS-Guided Portal Pressure Gradient and Hepatic Venous Pressure Gradient (time frame: Periprocedural). 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 24 Aug 2026.