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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07704203
Enrollment
150
Registered
2026-07-15
Start date
2026-08-01
Completion date
2030-10-01
Last updated
2026-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Cancer, Hepatocellular Carcinoma, Intrahepatic Cholangiocellular Carcinoma, Metastatic Hepatocellular Carcinoma

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.

Interventions

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.

Sponsors

Second Affiliated Hospital of Xi'an Jiaotong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Post-Hepatectomy Liver Failure (PHLF)Within 90 days after surgeryPost-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

MeasureTime frameDescription
Correlation between preoperative 3D-MRE regional stiffness parameters and future liver remnant functionBaseline (preoperative)Association between region-specific viscoelastic parameters (stiffness, storage modulus, loss modulus, damping ratio) and clinical liver function indices

Contacts

CONTACTKai Qu
qukai001@xjtu.edu.cn+8613609117104

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 16, 2026