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Completed

NCT Number: NCT07703540

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Muenster

Münster, North Rhine-Westphalia, 48149, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HVP-PPG and IVCP-PPG

Diagnostic Test

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Correlation between HVP and IVCP, Bland-Altman analysis of agreement and systematic bias

    Time frame: Intraprocedural measurement

  2. Agreement between PPG-HV and PPG-IVC

    Time frame: Intraprocedural measurement

  3. Reclassification across clinically significant portal hypertension thresholds (≥10 mmHg)

    Time frame: Intraprocedural measurement

  4. Intraprocedural variability of triplicate measurements

    Time frame: Intraprocedural measurement

  5. Procedural adverse events

    Time frame: Up to 72 hours

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Registry information

Acronym: EUS-VEIN

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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