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

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.

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Key information

Conditions

Hepatic Cancer Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Hepatocellular Carcinoma Intrahepatic Cholangiocellular Carcinoma Liver Diseases Liver Neoplasms Metastatic Hepatocellular Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Three-Dimensional Magnetic Resonance Elastography

Device

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.

Primary outcomes

Incidence of Post-Hepatectomy Liver Failure (PHLF)

Time frame: Within 90 days after surgery

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

Time frame: Baseline (preoperative)

Association between region-specific viscoelastic parameters (stiffness, storage modulus, loss modulus, damping ratio) and clinical liver function indices

Study contacts

Contact information is provided by the study sponsor or research team.

Kai Qu

CONTACT

[email protected]

+8613609117104

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Other

Registry information

Official study 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

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2030
First posted: Jul 15, 2026
Registry last updated: Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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