Portal Vein ThrombosisNCT07062289
Endoscopic Ultrasound-guided Measurement of Portal Vein Pressure Gradient
A study testing endoscopic ultrasound-guided portal pressure gradient in people with Portal Vein Thrombosis and Portal Hypertension Related to Cirrhosis, run by Zhejiang University.
Trial summary
This study aims to evaluate the accuracy and safety of a novel endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement technique in 42 adults with liver cirrhosis and portal vein thrombosis (blood clots in the liver's main vein), a condition where current standard testing (HVPG) fails to provide… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Portal Vein Thrombosis, Portal Hypertension Related to Cirrhosis
- What is being tested?
- endoscopic ultrasound-guided portal pressure gradient
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 30 Jun 2027
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 years old
- History of liver cirrhosis
- INR < 1.5
- Platelet count > 50 × 10⁹/L
- Patients agreed to HVPG and EUS-PPG measurements
Who cannot join
- Patients with ascites
- Patients with renal insufficiency
- Patients with active infection
- Patients with hepatic encephalopathy
- Critically ill patients
- Pregnant patients
Show all 10Show fewer
- Patients with immunodeficiency diseases (such as systemic lupus erythematosus)
- Patients with mental illness
- Patients with malignant tumors
- Patients who refused to undergo HVPG and EUS-PPG measurements
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study on the Measurement of Portal Vein Pressure Gradient Guided by Endoscopic Ultrasound Based on Portal Vein Thrombosis and Portal Hypertension
This study aims to evaluate the accuracy and safety of a novel endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement technique in 42 adults with liver cirrhosis and portal vein thrombosis (blood clots in the liver's main vein), a condition where current standard testing (HVPG) fails to provide reliable pressure readings. Participants will undergo both EUS-PPG (using a specialized needle under ultrasound guidance) and HVPG procedures to compare results; EUS-PPG will be performed under general anesthesia in a left-side lying position-an innovative approach-while also enabling immediate endoscopic treatment of bleeding veins if detected during the same session. The primary goals are to validate EUS-PPG's safety in this high-risk group, establish its correlation with HVPG, and pioneer an integrated diagnosis-treatment protocol to reduce hospital stays and costs. The study runs from July 2025 to June 2027 at Zhejiang University School of Medicine.
- Being tested
- endoscopic ultrasound-guided portal pressure gradient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic ultrasound-guided portal pressure gradientProcedure or surgery
This study employs an integrated endoscopic ultrasound-guided portal pressure gradient (EUS-PPG+) protocol uniquely designed for cirrhotic patients with portal vein thrombosis (PVT). Under general anesthesia in the left lateral decubitus position (novel positioning), a linear echoendoscope directs 22G needle puncture of the portal vein and inferior vena cava for direct pressure measurement, with real-time Doppler confirmation to avoid thrombosed vessels. Crucially, this intervention synchronizes diagnostic and therapeutic actions: if high-risk esophageal/gastric varices are identified during EUS, immediate endoscopic therapy (e.g., glue injection) is delivered in the same session. All participants additionally undergo standard hepatic venous pressure gradient (HVPG) measurement via transjugular access within 24 hours, enabling within-patient correlation analysis.
| Study group | Role | What they receive |
|---|---|---|
| hepatic venous pressure gradient, HVPG | Experimental | After puncturing the internal jugular vein, under the guidance of the image monitor, the balloon catheter is inserted into the hepatic vein along the blood vessel to measure the free hepatic venous pressure (FHVP), and then the balloon is inflated to measure the wedged hepatic venous pressure (WHVP). The difference between the two is the hepatic venous pressure gradient. Receives: Procedure: endoscopic ultrasound-guided portal pressure gradient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Portal Pressure Gradient Measured by HVPG and EUS-PPG Techniques
The internal jugular vein is punctured and the difference between the wedge hepatic venous pressure (WHVP) and the free hepatic venous pressure (FHVP) is measured as the hepatic venous pressure gradient (HVPG). Endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) refers to the measurement of data by passing the puncture needle through the digestive tract into the portal vein system, hepatic vein or inferior vena cava system under the guidance of a linear array ultrasound endoscope.Portal vein pressure (PVP): The normal portal vein pressure is 1.27-2.35 kPa (13-24 cmH2O)
Measured: From enrollment, treatment was completed within 1 week
Secondary outcomes (2)
Incidence of surgery-related complications
Complications: obvious abdominal pain and nausea, fever > 38.5°C
Measured: From enrollment, treatment was completed within 1 week
Direct medical cost of treatment
Direct medical cost of treatment:
Components: surgical consumables, anesthesia, drugs, ward fees, nursing Currency: RMB (yuan)
Measured: From enrollment, treatment was completed within 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Jul 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Portal Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaolong Zheng, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062289
- Sponsor's protocol ID
- 2025-0823
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The patient's basic data and information will be kept confidential
Publications
Martinez-Moreno B, Martinez Martinez J, Herrera I, Guilabert L, Rodriguez-Soler M, Bellot P, Miralles C, Pascual S, Irurzun J, Zapater P, Palazon-Azorin JM, Gil Guillen V, Jover R, Aparicio JR. Correlation of endoscopic ultrasound-guided portal pressure gradient measurements with hepatic venous pressure gradient: a prospective study. Endoscopy. 2025 Jan;57(1):62-67. doi: 10.1055/a-2369-0759. Epub 2024 Jul 18.
PubMed 39025130Zhang W, Peng C, Zhang S, Huang S, Shen S, Xu G, Zhang F, Xiao J, Zhang M, Zhuge Y, Wang L, Zou X, Lv Y. EUS-guided portal pressure gradient measurement in patients with acute or subacute portal hypertension. Gastrointest Endosc. 2021 Mar;93(3):565-572. doi: 10.1016/j.gie.2020.06.065. Epub 2020 Jun 29.
PubMed 32615178
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Measurement of Portal Vein Pressure Gradient Guided by Endoscopic Ultrasound Based on Portal Vein Thrombosis and Portal Hypertension
- ClinicalTrials.gov ID
- NCT07062289
- Acronym / sponsor ID
- 2025-0823
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 14 Jul 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.
This study aims to evaluate the accuracy and safety of a novel endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement technique in 42 adults with liver cirrhosis and portal vein thrombosis (blood clots in the liver's main vein), a condition where current standard testing (HVPG) fails to provide reliable pressure readings. Participants will undergo both EUS-PPG (using a specialized needle under ultrasound guidance) and HVPG procedures to compare results; EUS-PPG will be performed under general anesthesia in a left-side lying position-an innovative approach-while also enabling immediate endoscopic treatment of bleeding veins if detected during the same session. The primary goals are to validate EUS-PPG's safety in this high-risk group, establish its correlation with HVPG, and pioneer an integrated diagnosis-treatment protocol to reduce hospital stays and costs. The study runs from July 2025 to June 2027 at Zhejiang University School of Medicine.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hepatic venous pressure gradient, HVPG | Experimental | Procedure: endoscopic ultrasound-guided portal pressure gradientAfter puncturing the internal jugular vein, under the guidance of the image monitor, the balloon catheter is inserted into the hepatic vein along the blood vessel to measure the free hepatic venous pressure (FHVP), and then the balloon is inflated to measure the wedged hepatic venous pressure (WHVP). The difference between the two is the hepatic venous pressure gradient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years old
- History of liver cirrhosis
- INR < 1.5
- Platelet count > 50 × 10⁹/L
- Patients agreed to HVPG and EUS-PPG measurements
Key exclusion criteria (10 listed)
- Patients with ascites
- Patients with renal insufficiency
- Patients with active infection
- Patients with hepatic encephalopathy
- Critically ill patients
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 |
|---|---|---|
| endoscopic ultrasound-guided portal pressure gradientThis study employs an integrated endoscopic ultrasound-guided portal pressure gradient (EUS-PPG+) protocol uniquely designed for cirrhotic patients with portal vein thrombosis (PVT). Under general anesthesia in the left lateral decubitus position (novel positioning), a linear echoendoscope directs 22G needle puncture of the portal vein and inferior vena cava for direct pressure measurement, with real-time Doppler confirmation to avoid thrombosed vessels. Crucially, this intervention synchronizes diagnostic and therapeutic actions: if high-risk esophageal/gastric varices are identified during EUS, immediate endoscopic therapy (e.g., glue injection) is delivered in the same session. All participants additionally undergo standard hepatic venous pressure gradient (HVPG) measurement via transjugular access within 24 hours, enabling within-patient correlation analysis. | Procedure or surgery | hepatic venous pressure gradient, HVPG |
Primary outcome
Mean Portal Pressure Gradient Measured by HVPG and EUS-PPG Techniques
Time frame: From enrollment, treatment was completed within 1 week
The internal jugular vein is punctured and the difference between the wedge hepatic venous pressure (WHVP) and the free hepatic venous pressure (FHVP) is measured as the hepatic venous pressure gradient (HVPG). Endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) refers to the measurement of data by passing the puncture needle through the digestive tract into the portal vein system, hepatic vein or inferior vena cava system under the guidance of a linear array ultrasound endoscope.Portal vein pressure (PVP): The normal portal vein pressure is 1.27-2.35 kPa (13-24 cmH2O)
2 secondary outcomes
Incidence of surgery-related complications
Time frame: From enrollment, treatment was completed within 1 week
Direct medical cost of treatment
Time frame: From enrollment, treatment was completed within 1 week
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 14 Jul 2025.
- Results publication: PubMed 39025130Martinez-Moreno B, Martinez Martinez J, Herrera I, Guilabert L, Rodriguez-Soler M, Bellot P, Miralles C, Pascual S, Irurzun J, Zapater P, Palazon-Azorin JM, Gil Guillen V, Jover R, Aparicio JR. Correlation of endoscopic ultrasound-guided portal pressure gradient measurements with hepatic venous pressure gradient: a prospective study. Endoscopy. 2025 Jan;57(1):62-67. doi: 10.1055/a-2369-0759. Epub 2024 Jul 18.
- Results publication: PubMed 32615178Zhang W, Peng C, Zhang S, Huang S, Shen S, Xu G, Zhang F, Xiao J, Zhang M, Zhuge Y, Wang L, Zou X, Lv Y. EUS-guided portal pressure gradient measurement in patients with acute or subacute portal hypertension. Gastrointest Endosc. 2021 Mar;93(3):565-572. doi: 10.1016/j.gie.2020.06.065. Epub 2020 Jun 29.
- Individual participant dataSharing planned: No. The patient's basic data and information will be kept confidential
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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.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic ultrasound-guided portal pressure gradient in people with Portal Vein Thrombosis and Portal Hypertension Related to Cirrhosis, run by Zhejiang University.
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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Wei Wei (17530861504, wwze@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Portal Pressure Gradient Measured by HVPG and EUS-PPG Techniques (time frame: From enrollment, treatment was completed within 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07062289, which also lists 2 linked publications.
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 14 Jul 2025.