AzTrials
AzTrials

CirrhosisEUS-VEINNCT07703540

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

An observational study of Cirrhosis and Liver Disease Chronic, run by University Hospital Muenster at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HVP-PPG and IVCP-PPG
How many people
40 participants
Where
1 siteGermany
Study dates
1 Feb 2026to 15 May 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site
  • University Hospital Muenster

    Münster, North Rhine-Westphalia, 48149

Other trials in Germany

About this study

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.

Being tested
HVP-PPG and IVCP-PPG
Keywords
EUS-PPG, EUS, Portal hypertension, Portal vein pressure, Clinically significant portal hypertension (CSPH), Inferior vena cava pressure, Endoscopic ultrasound-guided portal pressure gradient
Medical subject headings
Fibrosis, Hypertension, Portal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HVP-PPG and IVCP-PPGDiagnostic 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).

Study groups in NCT07703540
Study groupRoleWhat they receive
HVP-PPG and IVCP-PPGPatients undergoing both measurements (HVP-PPG and IVCP-PPG)
Receives: Diagnostic Test: HVP-PPG and IVCP-PPG

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Intraprocedural

Secondary outcomes (5)
  1. Correlation between HVP and IVCP, Bland-Altman analysis of agreement and systematic bias

    Measured: Intraprocedural measurement

  2. Agreement between PPG-HV and PPG-IVC

    Measured: Intraprocedural measurement

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

    Measured: Intraprocedural measurement

  4. Intraprocedural variability of triplicate measurements

    Measured: Intraprocedural measurement

  5. Procedural adverse events

    Measured: Up to 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2026
  2. Study start1 Feb 2026
  3. Primary completion30 Apr 2026
  4. Study completion15 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07703540
Sponsor's protocol ID
MSPPG1
Acronym
EUS-VEIN
Status last verified
Feb 2026
First submitted
8 Jul 2026
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40251984
  • 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.

    PubMed 41046961
  • 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.

    PubMed 41748429
  • 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.

    PubMed 32615178
  • 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.

    PubMed 27212121
  • 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.

    PubMed 26238376
  • 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.

    PubMed 38945633
  • 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.

    PubMed 759258
  • 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.

    PubMed 32628153
  • 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.

    PubMed 40901597
  • 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.

    PubMed 38779643
  • 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.

    PubMed 39025130
  • 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.

    PubMed 40689144
  • 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.

    PubMed 37730125
  • 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.

    PubMed 40707208

Questions about this trial

What is this clinical trial studying?

An observational study of Cirrhosis and Liver Disease Chronic, run by University Hospital Muenster at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Agreement between mean hepatic vein pressure and mean inferior vena cava pressure measured during the same EUS-PPG session (time frame: Intraprocedural). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07703540, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in