Quantitative MRI and Outcomes of Liver Resection

Liver Cancer Clinical Trial

Official title:

Predicting the Outcomes of LIVEr Resection Using Quantitative Magnetic Resonance Imaging: the POLIVER Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06181318
• Other study ID #: POLIVER20230628
• Status: Not yet recruiting
• Start date: February 1, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: December 2023
• Source: University Hospital Heidelberg
• Contact: Arianeb Mehrabi, Professor
• Phone: 004962215636223
• Email: arianeb.mehrabi[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The present observational study aims to assess the benefit of this quantitative multiparametric magnetic resonance imaging (MRI) in clinical practice, to quantify future liver remnant performance, and to accurately predict the risk of liver failure after major hepatectomy, among patients undergoing major liver resection. The main questions to be answered are: - Can multiparametric MRI predict the postoperative liver function? - Can multiparametric MRI predict the postoperative liver-specific complications as well as mortality? With ethical approval and fully informed consent, patients being considered for major liver resection will undergo clinical assessment, blood sampling, and multiparametric MRI before surgery. For the primary outcome, 33 participants will be needed to detect a minimum correlation coefficient of 0.2 with 5% significance and 80% power.

Description:

In patients being considered for major liver resection, volumetric and functional evaluation of the future liver remnant should ideally be combined to reduce the risk of posthepatectomy liver failure (PHLF) and other adverse outcomes. Quantitative multiparametric magnetic resonance imaging (MRI) can measure liver health by assessing parenchyma fibrosis and inflammation. This has shown promising results in predicting postoperative liver performance. The current study aims to assess the benefit of this MRI-based technology in clinical practice, to quantify future liver remnant performance, and to accurately predict the risk of liver failure after major hepatectomy. Prospective observational clinical study in a single hepatobiliary surgery center. With ethical approval and fully informed consent, patients being considered for major liver resection will undergo clinical assessment, blood sampling, and multiparametric MRI before surgery. Postoperative liver function and complications will be reported for 90 days after surgery. Preoperative MRI assessment scores and postoperative outcomes will be correlated to determine whether multiparametric MRI scans can accurately predict the risk of postoperative liver-specific complications (primary endpoint) as well as postoperative liver function, surgery-specific complications, the overall complication rate, quality of hospital care, and length of stay. For the primary outcome, 33 participants will be needed to detect a minimum correlation coefficient of 0.2 with 5% significance and 80% power. This study will include 33 patients and results are expected in 2024. If successful, this investigation will support the use of quantitative multiparametric MRI to guide surgical decision-making. This will represent a non-invasive, diagnostic, volumetric, and segmental functional test for the preoperative workup of patients being considered for major hepatectomy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 33
• Est. completion date: April 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (= 18 years old) patients with an indication for elective major liver resection.
• Any benign or malignant indication.
• Provision of informed consent.
• MRI scan performed = 7 days before surgery

Exclusion Criteria:

• Previous liver resection.
• Previous volume-enhancing procedures, such as portal vein embolization.
• Previous microwave ablation of liver lesions.
• Contraindication and/or inability to undergo contrast-enhanced MRI scan (including implanted metallic devices or foreign bodies, claustrophobia and contraindication for Primovist® administration).

Related Conditions & MeSH terms

• Bile Leak
• Hepatic Insufficiency
• Liver Cancer
• Liver Failure
• Liver Metastases

Intervention

Diagnostic Test:
• Multiparametric MRI scan of the liver
MRI scans will be performed at the Champalimaud Foundation using a 1.5T scanner after patients have fasted for 4 hours. Transverse abdominal T1 maps will be acquired to estimate extracellular fluid (which increases in cases of fibrosis and inflammation) and T2* maps will be acquired to estimate liver iron levels. These quantitative MRI maps will be laid onto the volumetric images of Couinaud segments. Multi-slice quantitative maps will be generated using Liver MultiScan software (Perspectum, UK) with operators blinded to patient status. T1 measurements will be adjusted for the iron level to give iron-corrected T1 maps (cT1). Reference ranges for cT1 have been defined in the general population. PDFF maps of the liver will be calculated using MRI multi-echo and spoiled-gradient-echo acquisition. No intravenous contrast agents will be used in Liver MultiScan maps and the total scan duration will be approximately 30 minutes.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Heidelberg	Fundacao Champalimaud

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predicting the posthepatectomy liver failure after major liver resection	Correlation between future liver remnant performance (combined measure of liver volume, PDFF, and cT1) and posthepatectomy liver failure after major liver resection	90 days postoperative
Primary	Predicting the posthepatectomy biliary leakage after major liver resection	Correlation between future liver remnant performance (combined measure of liver volume, PDFF, and cT1) and posthepatectomy biliary leakage after major liver resection	90 days postoperative
Primary	Predicting the posthepatectomy hemorrhage after major liver resection	Correlation between future liver remnant performance (combined measure of liver volume, PDFF, and cT1) and posthepatectomy hemorrhage after major liver resection	90 days postoperative
Secondary	Correlation between remnant liver function after major liver resection and incidence of major complications	Correlation between future liver remnant performance (combined measure of liver volume, PDFF, and cT1) and major complications according to Clavien-Dindo classification (>IIIA) after major liver resection	90 days postoperative
Secondary	Correlation between remnant liver function after major liver resection and postoperative mortality	Correlation between future liver remnant performance (combined measure of liver volume, PDFF, and cT1) and mortality according to Clavien-Dindo classification (>IIIA) after major liver resection	90 days postoperative