Evaluation of Remnant Liver Function Using Primovist-enhanced MRI Before Resection/Ablation of Hepatocellular Carcinoma
This trial is active, not recruiting.
|Conditions||carcinoma, hepatocellular, liver dysfunction|
|Sponsor||Seoul National University Hospital|
|Start date||December 2011|
|End date||February 2014|
|Trial size||71 participants|
|Trial identifier||NCT01490203, LIFE_ISS_2011|
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).
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Hwasun-Gun, Korea, Republic of||Cheonnam University Hwasun Hospital||no longer recruiting|
|Seoul, Korea, Republic of||Asan Medical Center||no longer recruiting|
|Seoul, Korea, Republic of||Seoul National University Hospital||no longer recruiting|
|Seoul, Korea, Republic of||The Catholic University of Korea, Seoul St. Mary's Hospital||no longer recruiting|
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
time frame: 3 days (upto 5 days) after surgery
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
time frame: within 7 days before, and 3 to 5 days after surgery
Analysis of clinical and MRI parameters of postoperative complication and morbidity
time frame: upto 3 months (plus minus 1 week) after discharge
Exploratory analysis of MRI parameters and ICG R15 derived from potential liver donors
time frame: within 3 days of ICG R15 test
Male or female participants at least 18 years old.
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.
|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|
|Principal investigator||Jeong Min Lee, MD, PhD|
|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.|
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