Inferior Vena Cava Pressure as Alternative to Hepatic Venous Pressure for EUS-guided Portal Pressure Gradient Measurement (EUS-VEIN)

July 8, 2026 updated by: Prof. Dr. Michael Praktiknjo, University Hospital Muenster
This study investigates a new, simplified approach to measuring blood pressure within the liver (portal hypertension) using Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement (EUS-PPG). While this minimally invasive method traditionally relies on a hepatic vein as the baseline reference point, advanced liver scarring can make these veins twisted and highly difficult to access. To address this challenge, our study evaluates the Inferior Vena Cava (IVC)-the body's largest main vein-as an alternative reference site. Currently, it remains scientifically unproven whether the inferior vena cava or the hepatic vein provides the more reliable and accurate pressure reading for calculation, as anatomical distortion from cirrhosis can affect both areas differently. By measuring and comparing both venous compartments during a single, clinically scheduled endoscopy session, this study aims to determine if the pressures are truly interchangeable. Ultimately, this research will clarify which vessel serves as the optimal reference point, helping to establish a safer, more reliable diagnostic standard for patients with complex vascular anatomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Germany, 48149
        • University Hospital Muenster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of consecutive adult patients ($\ge18$ years) undergoing a clinically indicated EUS-PPG measurement (e.g., for liver disease evaluation, fibrosis staging, or portal hypertension assessment).

Description

Inclusion Criteria:

  • Consecutive adult patients (≥18 years) undergoing clinically indicated EUS-guided portal pressure gradient measurement

Exclusion Criteria:

  • severe coagulopathy (INR >2.0), thrombocytopenia (<50,000/µL)
  • large-volume ascites
  • gastric varices precluding safe vascular puncture
  • known hepatic vein thrombosis or Budd-Chiari syndrome
  • altered IVC anatomy such as patients after liver transplantation with piggy-back anastomosis
  • contraindication to upper gastrointestinal endoscopy or sedation
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HVP-PPG and IVCP-PPG
Patients undergoing both measurements (HVP-PPG and IVCP-PPG)
Diagnostic test: HVP-PPG and IVCP-PPG
During a clinically indicated endoscopic ultrasound (EUS), patients undergo portal pressure gradient (PPG) measurement using a linear-array echoendoscope and a dedicated needle system (22G or 25G). The intervention utilizes a transgastric approach to sequentially measure pressures in three vessels: a left intrahepatic portal vein branch, a hepatic vein, and the inferior vena cava (IVC). The IVC is safely punctured through a window covered by liver tissue. Pressures are measured in triplicate per vessel. This protocol uniquely calculates two distinct gradients within the same procedural session: HVP-PPG: Calculated as the mean portal vein pressure minus the mean hepatic vein pressure (HVP). IVCP-PPG: Calculated as the mean portal vein pressure minus the mean inferior vena cava pressure (IVCP).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agreement between mean hepatic vein pressure and mean inferior vena cava pressure measured during the same EUS-PPG session
Time Frame: Intraprocedural
Based on prior reproducibility data for EUS-guided portal pressure measurements, a predefined absolute difference of >1 mmHg between HVP and IVCP was considered clinically relevant. Differences ≤1 mmHg after rounding to the nearest whole mmHg were considered hemodynamically equivalent, reflecting clinical pressure reporting practice.
Intraprocedural

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between HVP and IVCP, Bland-Altman analysis of agreement and systematic bias
Time Frame: Intraprocedural measurement
Intraprocedural measurement
Agreement between PPG-HV and PPG-IVC
Time Frame: Intraprocedural measurement
Intraprocedural measurement
Reclassification across clinically significant portal hypertension thresholds (≥10 mmHg)
Time Frame: Intraprocedural measurement
Intraprocedural measurement
Intraprocedural variability of triplicate measurements
Time Frame: Intraprocedural measurement
Intraprocedural measurement
Procedural adverse events
Time Frame: Up to 72 hours
Up to 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Actual)

April 30, 2026

Study Completion (Actual)

May 15, 2026

Study Registration Dates

First Submitted

July 8, 2026

First Submitted That Met QC Criteria

July 8, 2026

First Posted (Actual)

July 14, 2026

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

July 8, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSPPG1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cirrhosis

Clinical Trials on HVP-PPG and IVCP-PPG

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe