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

July 10, 2026 updated by: Second Affiliated Hospital of Xi'an Jiaotong University

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 90 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline (preoperative)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

October 1, 2030

Study Registration Dates

First Submitted

July 10, 2026

First Submitted That Met QC Criteria

July 10, 2026

First Posted (Actual)

July 15, 2026

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 10, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTUSAH-MRE-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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