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

Second Affiliated Hospital of Xi'an Jiaotong University0 个研究点目标入组 150 人开始时间: 2026年8月1日最近更新: 2026年7月15日

适应症

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 150
主要终点: Incidence of Post-Hepatectomy Liver Failure (PHLF)

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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

排除标准

•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

结局指标

主要结局

Incidence of Post-Hepatectomy Liver Failure (PHLF)

时间窗: 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.

次要结局

Correlation between preoperative 3D-MRE regional stiffness parameters and future liver remnant function(Baseline (preoperative))

研究者

发起方

Second Affiliated Hospital of Xi'an Jiaotong University

申办方类型

Other

责任方

Sponsor

相似试验

尚未招募

4 期

Prediction of Complications in Hepatic Tumors

NCT07358975Rigshospitalet, Denmark192

尚未招募

不适用

Study on patients undergoing liver surgery to check how well the liver is working before surgery and to predict chances of liver problems after surgery and also to devolep a pictorial chart which will help in predication of liver failure.

CTRI/2025/09/094078Tata Memorial Hospital100

已完成

不适用

Role of Fibro Scan in detecting transient liver changes in patients undergoing Laparoscopic surgery

CTRI/2024/04/066122AIIMS Mangalagiri Institution70

尚未招募

不适用

A study on short-term recovery results after liver surgery at a major cancer hospital

CTRI/2025/10/096423N.A100

尚未招募

不适用

Preliminary Evaluation of Clinical Application of SPECT Imaging Targeting GPC3

NCT07353333Union Hospital, Tongji Medical College, Huazhong University of Science and Technology6