Clinical trial NCT01490203: Evaluation of Remnant Liver Function Using Primovist-enhanced MRI Before Resection/Ablation of Hepatocellular Carcinoma
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Hepatocellular
Liver Dysfunction
Keywords: Gd-EOB-DTPA
MRI
Hepatectomy
Hepatocellular Carcinoma
Liver Function Tests
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Bayer
name: Seoul St. Mary's Hospital
name: Asan Medical Center
name: Chonnam National University Hospital
First posted: 2011-12-12
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Group 1: Patients who will undergo hepatic resection/RFA for HCC. Group 2: Potential liver donors with normal hepatic function.

Brief summary: 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).

Detailed description: 1. 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.
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/RFA.

Eligibility criteria: 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 (including total hepatectomy for transplantation) or radiofrequency ablation 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 chemotherapy
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.

Primary outcomes:
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
timeFrame: 3 days (upto 5 days) after surgery
Secondary outcomes:
measure: 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
timeFrame: within 7 days before, and 3 to 5 days after surgery
measure: Analysis of clinical and MRI parameters of postoperative complication and morbidity
timeFrame: upto 3 months (plus minus 1 week) after discharge
measure: Exploratory analysis of MRI parameters and ICG R15 derived from potential liver donors
timeFrame: within 3 days of ICG R15 test
Other outcomes:
Locations:
city: Hwasun-Gun
country: Korea, Republic of
facility: Cheonnam University Hwasun Hospital
state: Cheonnam Province
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yoon JH, Choi JI, Jeong YY, Schenk A, Chen L, Laue H, Kim SY, Lee JM. Pre-treatment estimation of future remnant liver function using gadoxetic acid MRI in patients with HCC. J Hepatol. 2016 Dec;65(6):1155-1162. doi: 10.1016/j.jhep.2016.07.024. Epub 2016 Jul 28.