University Hospital Muenster
Münster, North Rhine-Westphalia, 48149, Germany
NCT Number: NCT07703540
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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Notify Me18 year and older
All sexes
Observational
Münster, North Rhine-Westphalia, 48149, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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.
Time frame: Intraprocedural measurement
Time frame: Intraprocedural measurement
Time frame: Intraprocedural measurement
Time frame: Intraprocedural measurement
Time frame: Up to 72 hours
University Hospital Muenster
Other
Acronym: EUS-VEIN
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