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Not yet recruiting NCT07704203

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

Observational Hepatic Cancer Hepatocellular Carcinoma Intrahepatic Cholangiocellular Carcinoma Metastatic Hepatocellular Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Three-Dimensional Magnetic Resonance Elastography.
Who it may be relevant to
Registry conditions: Hepatic Cancer, Hepatocellular Carcinoma, Intrahepatic Cholangiocellular Carcinoma, Metastatic Hepatocellular Carcinoma. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Prospective Study on Preoperative Regional Liver Function Assessment Using Three-Dimensional Magnetic Resonance Elastography for Predicting Surgical Risk and Postoperative Liver Failure in Patients Undergoing Hepatectomy for Primary or Metastatic Liver Cancer

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.

Interventions

  • Device Three-Dimensional Magnetic Resonance Elastography
    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 postoper

Primary outcome measures

  • Incidence of Post-Hepatectomy Liver Failure (PHLF) [Time frame: Within 90 days after surgery]
Secondary outcome measures (1)
  • Correlation between preoperative 3D-MRE regional stiffness parameters and future liver remnant function [Time frame: Baseline (preoperative)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07704203 · XJTUSAH-MRE-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗