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Preoperative Evaluation of Future Remnant Liver Function Using Gd-EOB-DTPA Enhanced Magnetic Resonance Imaging in Patients Undergoing Hepatic Resection for Hepatocellular Carcinoma

18 Years
Open (Enrolling)
Carcinoma, Hepatocellular, Liver Dysfunction

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Trial Information

Preoperative Evaluation of Future Remnant Liver Function Using Gd-EOB-DTPA Enhanced Magnetic Resonance Imaging in Patients Undergoing Hepatic Resection for Hepatocellular Carcinoma

1. Preoperative 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.

2. 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.

3. 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.

Inclusion Criteria:

1. Patients with the diagnosis of HCC based on noninvasive diagnostic criteria of HCC
proposed by 2010 AASLD

2. Surgical resection of hepatic resection greater than 2 Couinaud segments is planned

3. Patients who provided the informed consent

Exclusion Criteria:

1. Patients younger than 18 yrs old

2. Patients who received hepatic surgery prior to this study

3. Patients who underwent TACE or RFA for greater than 2 segments within 3 months prior
to this study

4. Patients who received radiation treatment including the liver or systemic

5. Patients who underwent contrast enhanced liver MRI within 3 days prior to this study

6. Patients with severe renal dysfunction (Cr .2.5 mg/dL or GFR < 30mL/min)

7. Patients with hypersensitivity to gadolinium

8. Patients with uncorrectable hypokalemia

9. Pregnant women, or reproductive age women who will not agree with contraception
during this study period.

10. Patients with mental disorder which will interfere with voluntary agreement

11. Patients who have any contraindication to MRI (cardiac pacemaker, ferromagnetic
implants, etc.)

12. 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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Description:

Predicted RLF (HEF mL) = the sum of the individual HEF of each voxel in future remnant segment

Outcome Time Frame:

3 days (upto 5 days) after surgery

Safety Issue:


Principal Investigator

Jeong Min Lee, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital


Korea: Institutional Review Board

Study ID:




Start Date:

December 2011

Completion Date:

April 2013

Related Keywords:

  • Carcinoma, Hepatocellular
  • Liver Dysfunction
  • MRI
  • Hepatectomy
  • Hepatocellular Carcinoma
  • Liver Function Tests
  • Carcinoma
  • Liver Diseases
  • Carcinoma, Hepatocellular