Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06210178

Non-Invasive Portal and Hepatic Vein Pressure Estimation

Led by Leiden University Medical Center · Updated on 2024-01-18

50

Participants Needed

1

Research Sites

156 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Non-Invasive Portal and Hepatic Vein Pressure Estimation

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Eligible for liver transplantation screening (which excludes pregnancy).
  • Age 18 years or older and 75 years or younger.
  • Provided written informed consent.
Not Eligible

You will not qualify if you...

  • Claustrophobia, pacemaker, metal implants, or other reasons preventing MRI.
  • Psychiatric, addictive, or other disorders affecting ability to understand the study and give consent.

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Trial Site Locations

Total: 1 location

1

Leiden University Medical Center

Leiden, South Holland, Netherlands, 2333ZA

Actively Recruiting

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Research Team

H

Hildo J Lamb, PhD, MD

CONTACT

M

Maarten E Tushuizen, PhD, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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