Cirrhosis, Liver Disease Chronic, Portal Hypertension
Conditions
Keywords
EUS-PPG, EUS, Portal hypertension, Portal vein pressure, Clinically significant portal hypertension (CSPH), Inferior vena cava pressure, Endoscopic ultrasound-guided portal pressure gradient
Brief summary
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.
Interventions
DIAGNOSTIC_TESTHVP-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).
Sponsors
University Hospital Muenster
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement between mean hepatic vein pressure and mean inferior vena cava pressure measured during the same EUS-PPG session | 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
| Measure | Time frame |
|---|---|
| Correlation between HVP and IVCP, Bland-Altman analysis of agreement and systematic bias | Intraprocedural measurement |
| Agreement between PPG-HV and PPG-IVC | Intraprocedural measurement |
| Reclassification across clinically significant portal hypertension thresholds (≥10 mmHg) | Intraprocedural measurement |
| Intraprocedural variability of triplicate measurements | Intraprocedural measurement |
| Procedural adverse events | Up to 72 hours |
Countries
Germany
Outcome results
None listed