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

NCT07703540 | Completed

• 1 other identifier: MSPPG1
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis; Liver Disease Chronic; Portal Hypertension

Keywords

EUS-PPG; EUS; Portal hypertension; Portal vein pressure; Clinically significant portal hypertension (CSPH); Inferior vena cava pressure; Endoscopic ultrasound-guided portal pressure gradient

Outcome Measures

Primary Outcomes (1)

• Agreement between mean hepatic vein pressure and mean inferior vena cava pressure measured during the same EUS-PPG session

  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 Outcomes (5)

• 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

Study Arms (1)

HVP-PPG and IVCP-PPG

Patients undergoing both measurements (HVP-PPG and IVCP-PPG)

Diagnostic Test: HVP-PPG and IVCP-PPG

Interventions

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).

HVP-PPG and IVCP-PPG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

University Hospital Muenster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Related Publications (19)

• Santopaolo F, Giuli L, Tripodi G, Pallozzi M, Ponziani FR, Annicchiarico BE, Rizzatti G, Contegiacomo A, Posa A, Iezzi R, Talerico R, Gasbarrini A, Larghi A. Prognostic Role of Endoscopic Ultrasound Guided Direct Portal Pressure Gradient Measurement in Porto-Sinusoidal Vascular Disorder. Liver Int. 2025 May;45(5):e70096. doi: 10.1111/liv.70096.

  PMID: 40251984 BACKGROUND

• Benmassaoud A, Bessissow A, Samoukovic G, Wong P, Zhao X, Deschenes M, Sebastiani G, Cabrera T, Valenti D, Boucher LM, Pelage JP, Muchantef K, Cardenas A, Givis MA, White S, Bousquet-Dion G, Waked C, Jacques J, Rahme E, Geraci O, Martel M, Barkun A, Maedler-Kron C, Chen YI. EUS-Guided Liver Biopsy and Portal Pressure Measurement Compared With a Transjugular Approach: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2026 Jun;24(6):1601-1610. doi: 10.1016/j.cgh.2025.09.025. Epub 2025 Oct 3.

  PMID: 41046961 BACKGROUND

• Praktiknjo M, Farouk N, Wang Z, Stadtmann J, van de Loo D, Kimmann M, Gunia C, Meier JA, Uschner FE, Peiffer KH, Laleman W, Trebicka J, Braden B. Same Session Validation of a Custom-Built 22G With the Commercial 25G System for EUS-Guided Portal Pressure Gradient Measurement. United European Gastroenterol J. 2026 Mar;14(2):e70194. doi: 10.1002/ueg2.70194.

  PMID: 41748429 BACKGROUND

• Zhang W, Peng C, Zhang S, Huang S, Shen S, Xu G, Zhang F, Xiao J, Zhang M, Zhuge Y, Wang L, Zou X, Lv Y. EUS-guided portal pressure gradient measurement in patients with acute or subacute portal hypertension. Gastrointest Endosc. 2021 Mar;93(3):565-572. doi: 10.1016/j.gie.2020.06.065. Epub 2020 Jun 29.

  PMID: 32615178 BACKGROUND

• Rossle M, Blanke P, Fritz B, Schultheiss M, Bettinger D. Free Hepatic Vein Pressure Is Not Useful to Calculate the Portal Pressure Gradient in Cirrhosis: A Morphologic and Hemodynamic Study. J Vasc Interv Radiol. 2016 Aug;27(8):1130-7. doi: 10.1016/j.jvir.2016.03.028. Epub 2016 Jun 7.

  PMID: 27212121 BACKGROUND

• Silva-Junior G, Baiges A, Turon F, Torres F, Hernandez-Gea V, Bosch J, Garcia-Pagan JC. The prognostic value of hepatic venous pressure gradient in patients with cirrhosis is highly dependent on the accuracy of the technique. Hepatology. 2015 Nov;62(5):1584-92. doi: 10.1002/hep.28031. Epub 2015 Sep 30.

  PMID: 26238376 BACKGROUND

• Rodrigues SG, Delgado MG, Stirnimann G, Berzigotti A, Bosch J. Hepatic Venous Pressure Gradient: Measurement and Pitfalls. Clin Liver Dis. 2024 Aug;28(3):383-400. doi: 10.1016/j.cld.2024.03.009. Epub 2024 May 1.

  PMID: 38945633 BACKGROUND

• Groszmann RJ, Glickman M, Blei AT, Storer E, Conn HO. Wedged and free hepatic venous pressure measured with a balloon catheter. Gastroenterology. 1979 Feb;76(2):253-8.

  PMID: 759258 BACKGROUND

• Reiberger T, Schwabl P, Trauner M, Peck-Radosavljevic M, Mandorfer M. Measurement of the Hepatic Venous Pressure Gradient and Transjugular Liver Biopsy. J Vis Exp. 2020 Jun 18;(160). doi: 10.3791/58819.

  PMID: 32628153 BACKGROUND

• Singla N, Shantan V, Saraswat A, Singh AP. Advances in portal pressure measurement: Endoscopic techniques, challenges, and implications for liver transplantation. World J Hepatol. 2025 Aug 27;17(8):107679. doi: 10.4254/wjh.v17.i8.107679.

  PMID: 40901597 BACKGROUND

• Dhindsa BS, Tun KM, Fiedler A, Deliwala S, Saghir SM, Scholten K, Ramai D, Girotra M, Chandan S, Dhaliwal A, Bhat I, Singh S, Adler DG. Endoscopic ultrasound-guided portal pressure gradient measurement: a systematic review and meta-analysis. Ann Gastroenterol. 2024 May-Jun;37(3):356-361. doi: 10.20524/aog.2024.0882. Epub 2024 Apr 29.

  PMID: 38779643 BACKGROUND

• Martinez-Moreno B, Martinez Martinez J, Herrera I, Guilabert L, Rodriguez-Soler M, Bellot P, Miralles C, Pascual S, Irurzun J, Zapater P, Palazon-Azorin JM, Gil Guillen V, Jover R, Aparicio JR. Correlation of endoscopic ultrasound-guided portal pressure gradient measurements with hepatic venous pressure gradient: a prospective study. Endoscopy. 2025 Jan;57(1):62-67. doi: 10.1055/a-2369-0759. Epub 2024 Jul 18.

  PMID: 39025130 BACKGROUND

• Vanderschueren E, Laleman W, Bonne L, Maleux G, Wagner DR, Yeh C, Calvo A, Sendino O, Gines A, Baiges A, Bruno MJ, Garcia-Pagan JC, van der Merwe S. Endoscopic ultrasound-guided portosystemic pressure gradient measurement vs. transjugular balloon occlusion measurement in patients with cirrhosis (ENCOUNTER): A bicentric EU study. JHEP Rep. 2025 May 29;7(8):101466. doi: 10.1016/j.jhepr.2025.101466. eCollection 2025 Aug.

  PMID: 40689144 BACKGROUND

• Laleman W, Vanderschueren E, Mehdi ZS, Wiest R, Cardenas A, Trebicka J. Endoscopic procedures in hepatology: Current trends and new developments. J Hepatol. 2024 Jan;80(1):124-139. doi: 10.1016/j.jhep.2023.08.032. Epub 2023 Sep 18.

  PMID: 37730125 BACKGROUND

• Vanderschueren E, Praktiknjo M, Wiest R, Cardenas A, Trebicka J, Laleman W. Recent advances in clinical practice endohepatology: the endoscopic liver rush. Gut. 2025 Oct 8;74(11):1916-1930. doi: 10.1136/gutjnl-2025-334725.

  PMID: 40707208 BACKGROUND

• Wang TJ, Chang K, Rubin RA, Salgia R, Shami V, Watson A, Khara HS, Yeaton P, Adler DG, Bazarbashi AN, Benmassaoud A, Chen YI, Diehl DL, Draganov P, Duarte-Rojo A, Eves M, Fortune BE, Frandah WW, Gines A, Gjeorgjievski M, Henry ZH, James M, Jirapinyo P, Joshi T, Kankotia R, Khurana S, Kumar S, Kwo PY, Laleman W, Larghi AL, Mahon BS, McHenry SA, Mehta MJ, Mony S, Nilsson JE, Park WG, Sack J, Samarasena J, Santopaolo F, Teoh AY, Van Der Merwe S, Zucker SD, Ryou M. International Expert Delphi Consensus on Endoscopic Ultrasound-guided Portosystemic Pressure Gradient: Best Practices and Future Directions. Clin Gastroenterol Hepatol. 2025 Dec 16:S1542-3565(25)01033-X. doi: 10.1016/j.cgh.2025.12.007. Online ahead of print.

  PMID: 41412540 BACKGROUND

• Laleman W, Mertens J, Vanderschueren E, Praktiknjo M, Trebicka J. Advances in Endohepatology. Am J Gastroenterol. 2023 Oct 1;118(10):1756-1767. doi: 10.14309/ajg.0000000000002482. Epub 2023 Aug 23.

  PMID: 37610016 BACKGROUND

• Ripoll C, Groszmann R, Garcia-Tsao G, Grace N, Burroughs A, Planas R, Escorsell A, Garcia-Pagan JC, Makuch R, Patch D, Matloff DS, Bosch J; Portal Hypertension Collaborative Group. Hepatic venous pressure gradient predicts clinical decompensation in patients with compensated cirrhosis. Gastroenterology. 2007 Aug;133(2):481-8. doi: 10.1053/j.gastro.2007.05.024. Epub 2007 May 21.

  PMID: 17681169 BACKGROUND

• de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30.

  PMID: 35120736 BACKGROUND

MeSH Terms

Conditions

Fibrosis; Hypertension, Portal

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of hepatology

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: February 1, 2026
• Primary Completion: April 30, 2026
• Study Completion: May 15, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)