About this trial
How to accurately and safely evaluate regional liver function before hepatectomy remains an important unsolved problem in the surgical management of hepatocellular carcinoma (HCC). We plan to develop a non-invasive, functional 3D-MRE-based method for preoperative regional hepatic functional reserve assessment, and to evaluate its ability to predict surgical risk and postoperative liver failure in patients with HCC undergoing hepatectomy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-80 years
Pathologically or radiologically confirmed diagnosis of one of the following: hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or liver metastasis (e.g., from colorectal cancer)
Scheduled to undergo curative hepatectomy
Child-Pugh class A or B liver function
Disqualifiers
Contraindication to MRI (e.g., non-MRI-compatible implants, severe claustrophobia)
Child-Pugh class C liver function
Prior history of liver resection or liver transplantation
Presence of extrahepatic metastasis
Trial population
This study will enroll adult patients with primary or metastatic liver cancer, including hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or liver metastases (e.g., from colorectal cancer), who are scheduled to undergo curative hepatectomy at the Second Affiliated Hospital of Xi'an Jiaotong University. Eligible patients will have preserved liver function (Child-Pugh class A or B) and adequate future liver remnant volume based on standard preoperative volumetric assessment. Patients will be consecutively recruited from the hepatobiliary surgery outpatient and inpatient services of the study center prior to their scheduled surgery.
Trial design
Cohort
Prospective
Treatments tested in this trial
Three-Dimensional Magnetic Resonance Elastography
DevicePatients scheduled for hepatectomy will undergo a preoperative three-dimensional magnetic resonance elastography (3D-MRE) examination in addition to standard-of-care evaluation. 3D-MRE will be used to quantify regional hepatic stiffness and viscoelastic parameters (including shear stiffness, storage modulus, loss modulus, and damping ratio) across different liver segments, with particular attention to the future liver remnant. These parameters will be analyzed for their association with postoperative liver function and the occurrence of post-hepatectomy liver failure. The examination does not alter the standard surgical decision-making process.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of Post-Hepatectomy Liver Failure (PHLF)
Post-hepatectomy liver failure will be defined and graded according to the International Study Group of Liver Surgery (ISGLS) criteria (Grade A/B/C), based on postoperative bilirubin and INR values.
Secondary outcomes
Correlation between preoperative 3D-MRE regional stiffness parameters and future liver remnant function
Association between region-specific viscoelastic parameters (stiffness, storage modulus, loss modulus, damping ratio) and clinical liver function indices
Locations
Sponsors and contacts
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