Preoperative 3D Magnetic Resonance Elastography for Predicting Surgical Risk in Patients Undergoing Hepatectomy

N/ANot Yet RecruitingNCT07704203

Second Affiliated Hospital of Xi'an Jiaotong University150 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Hepatic Cancer Hepatocellular Carcinoma Intrahepatic Cholangiocellular Carcinoma Metastatic Hepatocellular Carcinoma

Interventions

Patients 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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 * Able to tolerate MRI examination * Provision of signed and dated informed consent Exclusion Criteria: * 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 * Emergency surgery (e.g., due to tumor rupture) * Severe cardiopulmonary or renal dysfunction precluding surgery * Pregnant or breastfeeding women * Unwillingness or inability to comply with study procedures or follow-up

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.

Time frame: Within 90 days after surgery

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

Time frame: Baseline (preoperative)

Data from ClinicalTrials.gov

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