Pre-Surgical Treatment or Radio Frequency Ablation (RFA) Evaluation of Future Remnant Liver Function Using Gd-EOB-DTPA Enhanced MRI in Patients Undergoing Hepatic Resection /RFA for Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 4
- 主要终点
- Correlation of hepatic extraction fraction (HEF) of future remnant liver function (RLF) obtained from Gd-EOB-DTPA enhanced MRI with postoperative ICG R15 clearance test results
研究概览
简要总结
The purpose of this study is to determine whether the global and segmental hepatic uptake and excretion of Gd-EOB-DTPA on Gd-EOB-DTPA-enhanced liver MRI correlates with standard liver function test results in the patients with Hepatocellular Carcinoma (HCC) before major hepatic resection or radiofrequency ablation (RFA).
详细描述
- Preoperative/RFA assessment of remnant liver function is important for avoiding posthepatectomy liver failure. However, the function of the future remnant is decreased in patients with chronic liver disease or cirrhosis, compared to that of healthy patients with an equal volume. Therefore, volume-based estimation of hepatic reserve function is inadequate for patients with hepatic dysfunction.
- Standard clinical liver function tests, such as ICG clearance rate or Child-Pugh score, provides measurements of the global hepatic function, but cannot evaluate the functional distribution in the liver. Gd-EOB-DTPA (Gadoxetic acid, Primovist®, Bayer Schering) enhanced MRI has been recently demonstrated to have the potential to be an imaging-based liver function test, with the possibility to detect functional differences on a regional or even segmental level.
- Gd-EOB-DTPA-enhanced liver MRI may be able to assess not only global but also segmental liver function in patients with hepatocellular carcinoma (HCC) who have a relatively high risk for developing liver failure after surgical resection due to coexistent hepatic damage by chronic viral hepatitis and/or cirrhosis preoperatively.
The purpose of this study is to determine whether the global and segmental hepatic uptake and excretion of Gd-EOB-DTPA on Gd-EOB-DTPA-enhanced liver MRI correlates with standard liver function test results in the patients with HCC before major hepatic resection/RFA.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with the diagnosis of HCC based on noninvasive diagnostic criteria of HCC proposed by 2010 AASLD
- •Surgical resection of hepatic resection greater than 2 Couinaud segments (including total hepatectomy for transplantation) or radiofrequency ablation is planned
- •Patients who provided the informed consent
排除标准
- •Patients younger than 18 yrs old
- •Patients who received hepatic surgery prior to this study
- •Patients who underwent TACE or RFA for greater than 2 segments within 3 months prior to this study
- •Patients who received radiation treatment including the liver or systemic chemotherapy
- •Patients who underwent contrast enhanced liver MRI within 3 days prior to this study
- •Patients with severe renal dysfunction (Cr .2.5 mg/dL or GFR < 30mL/min)
- •Patients with hypersensitivity to gadolinium
- •Patients with uncorrectable hypokalemia
- •Pregnant women, or reproductive age women who will not agree with contraception during this study period.
- •Patients with mental disorder which will interfere with voluntary agreement
- •Patients who have any contraindication to MRI (cardiac pacemaker, ferromagnetic implants, etc.)
- •Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrollment or could interfere with the completion of the study.
研究组 & 干预措施
Group 1: HCC resection/RFA
Patients who will undergo resection of at least two hepatic segments for HCC or radiofrequency ablation (RFA) for HCC and underwent gadoxetic acid (Gd-EOB-DTPA)-enhanced MRI
干预措施: Gd-EOB-DTPA (Drug)
Group 1: HCC resection/RFA
Patients who will undergo resection of at least two hepatic segments for HCC or radiofrequency ablation (RFA) for HCC and underwent gadoxetic acid (Gd-EOB-DTPA)-enhanced MRI
干预措施: MRI (Procedure)
Group 2: Potential liver donor
Potential liver donors with normal hepatic function and and underwent gadoxetic acid (Gd-EOB-DTPA)-enhanced MRI
干预措施: Gd-EOB-DTPA (Drug)
Group 2: Potential liver donor
Potential liver donors with normal hepatic function and and underwent gadoxetic acid (Gd-EOB-DTPA)-enhanced MRI
干预措施: MRI (Procedure)
结局指标
主要结局
Correlation of hepatic extraction fraction (HEF) of future remnant liver function (RLF) obtained from Gd-EOB-DTPA enhanced MRI with postoperative ICG R15 clearance test results
时间窗: 3 days (upto 5 days) after surgery
Predicted RLF (HEF mL) = the sum of the individual HEF of each voxel in future remnant segment
次要结局
- Correlation of various functional and volumetric parameters derived from Gd-EOB-DTPA enhanced MRI and clinical liver function tests obtained before and after surgical resection(within 7 days before, and 3 to 5 days after surgery)
- Analysis of clinical and MRI parameters of postoperative complication and morbidity(upto 3 months (plus minus 1 week) after discharge)
- Exploratory analysis of MRI parameters and ICG R15 derived from potential liver donors(within 3 days of ICG R15 test)
研究者
Jeong Min Lee
Associate Professor
Seoul National University Hospital