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

NCT07704203 | Not Yet Recruiting

• 1 other identifier: XJTUSAH-MRE-001
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hepatic Cancer; Hepatocellular Carcinoma; Intrahepatic Cholangiocellular Carcinoma; Metastatic Hepatocellular Carcinoma

Outcome Measures

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.

  Within 90 days after surgery

Secondary Outcomes (1)

• Correlation between preoperative 3D-MRE regional stiffness parameters and future liver remnant function

  Baseline (preoperative)

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Kai Qu

CONTACT

+8613609117104; qukai001@xjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2030
• Last Updated: July 15, 2026

Record last verified: 2026-07