NCT06181318

Quantitative MRI and Outcomes of Liver Resection

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 33 (estimated)
• Sponsor: University Hospital Heidelberg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Liver Cancer
• Liver Failure
• Bile Leak
• Liver Metastases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-12-31
• Completion: 2025-04-30
• First posted: 2023-12-26
• Last updated: 2023-12-26