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NCT Number: NCT06210178

Non-Invasive Portal and Hepatic Vein Pressure Estimation

Background Portal hypertension (PH) is a spectrum of complications of end-stage liver disease (ESLD) and cirrhosis, with severe manifestations including ascites and gastroesophageal varices. It is therefore important that timely and easily diagnosing PH has relevant prognostic and therapeutic implications. The current gold standard to evaluate PH is by hepatic vein catheterization using the transjugular approach, and measuring the hepatic venous pressure gradients (HVPG).

Time-resolved, three-dimensional, three-directional velocity-encoded MRI, also termed four-dimensional (4D) flow MRI, has been shown superior accuracy over conventional two-dimensional (2D) phase-contrast MRI, in particular for quantification of regurgitant volumes and severity of cardiac shunts. Recently, the investigators developed new imaging methods based on 4D flow MRI for visualization of the vasculature of the abdominal blood flow circulation including the portal vein. Using the newly developed computation fluid dynamics (CFD) model the investigators could determine the absolute local blood pressure in the portal vein. Preliminary data in healthy volunteers seem promising, however, data in patients with ESLD including the correlation with invasively measured HVPG are lacking.

Objectives The primary objective is to develop and validate noninvasive CFD and 4D Flow MRI based HVPG calculation to estimate portal pressure in patients with end-stage liver disease (ESLD).

Methods In 50 adult patients with ESLD, submitted for liver transplantation (LT) screening, HVPG measurements using the transjugular approach according to the standard LT screening protocol, will be extended by 4D flow MRI measurements.

Anticipated results In patients with ESLD, portal pressure can be measured by 4D flow MRI and will replace the invasive transjugular approach. The measurements can be directly incorporated in the LT screening. Moreover, the possibility to easily measure portal pressure will be relevant for all patients with ESLD at risk for PH.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Patients will undergo a single non-invasive MRI-examination of one hour long after a four hour period of fasting. The risks associated with non-invasive MRI examinations is neglectable.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

Location status: Recruiting

Location contact

Hildo J Lamb, PhD, MD

CONTACT

[email protected]

715269111 ext. +31

Paul R Roos, MSc

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Eligible for liver transplantation (LT) screening (which excludes pregnancy).
  • Age ≥ 18 years and ≤ 75 (since >75 is a contraindication for LT).
  • Written informed consent.

Exclusion criteria

  • Exclusion criteria for MRI (claustrophobia, pacemaker, metal implants, etc.).
  • A psychiatric, addictive or any other disorder that compromises the subjects ability to understand the study content and to give written informed consent for participation in the study.

Treatment and study plan

Magnetic Resonance Imaging

Diagnostic Test

MRI scans including abdominal 4D Flow MRI.

Primary outcomes

  1. Noninvasive HVPG

    Time frame: Within 4 years after enrollment.

    4D Flow MRI and Computational Fluid Dynamics (CFD) based Hepatic Venous Pressure Gradient (HVPG) calculation to estimate portal pressure.

Study contacts

Contact information is provided by the study sponsor or research team.

Hildo J Lamb, PhD, MD

CONTACT

[email protected]

715269111 ext. +31

Maarten E Tushuizen, PhD, MD

CONTACT

[email protected]

715269111 ext. +31

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Official study title

Non-Invasive Portal and Hepatic Vein Pressure Estimation: MRI-Guided Diagnostics for Chronic Liver Disease

Acronym: NONEEDLES

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 18, 2024
Registry last updated
Jan 18, 2024

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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