Non-Invasive Portal and Hepatic Vein Pressure Estimation (NONEEDLES)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Portal Hypertension
• Intervention / Treatment: Diagnostic test: Magnetic Resonance Imaging

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hildo J Lamb, PhD, MD; Phone Number: +31 715269111; Email: h.j.lamb@lumc.nl
• Study Contact Backup: Name: Maarten E Tushuizen, PhD, MD; Phone Number: +31 715269111; Email: levertransplantatie@lumc.nl

Study Locations

• Netherlands
  • Zuid-Holland
    • Leiden, Zuid-Holland, Netherlands, 2333ZA
      • Recruiting
      • Leiden University Medical Center
      • Contact: Hildo J Lamb, PhD, MD; Phone Number: +31 715269111; Email: h.j.lamb@lumc.nl
      • Sub-Investigator: Paul R Roos, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: MRI; Noninvasive MRI is performed.	Diagnostic test: Magnetic Resonance Imaging; MRI scans including abdominal 4D Flow MRI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Noninvasive HVPG	4D Flow MRI and Computational Fluid Dynamics (CFD) based Hepatic Venous Pressure Gradient (HVPG) calculation to estimate portal pressure.	Within 4 years after enrollment.

Collaborators and Investigators

• Sponsor: Leiden University Medical Center
• Investigators: Principal Investigator: Hildo J Lamb, PhD, MD, Leiden University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 21, 2023
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging; Noninvasive; Computational Fluid Dynamics; Meal challenge
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Hypertension, Portal
• Other Study ID Numbers: NNDLS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to share the individual participant data (IPD) outside of our research group.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No