NCT07782554

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
Last Updated

August 24, 2026

Status Verified

July 1, 2026

Enrollment Period

1.3 years

First QC Date

July 19, 2026

Last Update Submit

August 19, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Periprocedural

Secondary Outcomes (3)

  • Difference Between Distal-to-Obstruction and Proximal-to-Obstruction EUS-Guided Portal Pressure Gradients

    Periprocedural

  • Difference Between Distal-to-Obstruction EUS-Guided Portal Pressure Gradient and Hepatic Venous Pressure Gradient

    Periprocedural

  • Difference in Distal-to-Obstruction EUS-Guided Portal Pressure Gradient Between Patients With and Without Variceal Bleeding

    Baseline

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Age ≥18 years; Confirmed diagnosis of cirrhosis complicated by portal venous obstructionbased on clinical, laboratory, and imaging findings; Written informed consent;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2026

First Posted

August 24, 2026

Study Start

March 1, 2025

Primary Completion

June 30, 2026

Study Completion

June 30, 2026

Last Updated

August 24, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations