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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorSecond Affiliated Hospital of Xi'an Jiaotong University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

1

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)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: