Non-Invasive Portal and Hepatic Vein Pressure Estimation

NCT06210178 | Recruiting

• 1 other identifier: NNDLS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Portal Hypertension

Keywords

Magnetic Resonance Imaging; Computational Fluid Dynamics; Noninvasive; Meal challenge

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

MRI

OTHER

Noninvasive MRI is performed.

Diagnostic Test: Magnetic Resonance Imaging

Interventions

Magnetic Resonance Imaging DIAGNOSTIC_TEST

MRI scans including abdominal 4D Flow MRI.

MRI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

RECRUITING

MeSH Terms

Conditions

Hypertension, Portal

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Hildo J Lamb, PhD, MD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hildo J Lamb, PhD, MD

CONTACT

715269111; h.j.lamb@lumc.nl

Maarten E Tushuizen, PhD, MD

CONTACT

715269111; levertransplantatie@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiovascular Imaging, Professor of Radiology, Principal Investigator

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 18, 2024
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)