Evaluation of Remnant Liver Function Using Primovist-enhanced MRI Before Resection/Ablation of Hepatocellular Carcinoma (LiFE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01490203|
Recruitment Status : Completed
First Posted : December 12, 2011
Last Update Posted : March 23, 2018
|Condition or disease||Intervention/treatment|
|Carcinoma, Hepatocellular Liver Dysfunction||Drug: Gd-EOB-DTPA Procedure: MRI|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||71 participants|
|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 Start Date :||December 2011|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||December 2016|
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
Group 2: Potential liver donor
Potential liver donors with normal hepatic function and and underwent gadoxetic acid (Gd-EOB-DTPA)-enhanced MRI
- 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 ]Predicted RLF (HEF mL) = the sum of the individual HEF of each voxel in future remnant segment
- 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 ]
- Functional parameters derived from Gd-EOB-DTPA enhanced MRI include hepatic extraction fraction [HEF], input-relative blood flow [irBF], hepatocellular uptake index [HUI], liver to spleen ratio (LSR).
- Volumetric parameters include global liver volume and remnant liver volume.
- Clinical liver function tests include ICG R15, MELD score and Child-Pugh score.
- ICG R15 [Indocyanine green retention at 15 minutes, %] test will be performed within 3 days of preoperative MRI and 3 days after surgical resection.
- Analysis of clinical and MRI parameters of postoperative complication and morbidity [ Time Frame: upto 3 months (plus minus 1 week) after discharge ]
Clinical parameters refer to the following.
- Frequency of POD#5 days 50-50 criteria
- Evaluation of operation related complication
- Incidence of hepatic failure or death
- Functional and volumetric MRI parameters of patients with postoperative complication and morbidity will be evaluated.
- Correlation of MRI parameters with laboratory liver function tests.
- Exploratory analysis of MRI parameters and ICG R15 derived from potential liver donors [ Time Frame: within 3 days of ICG R15 test ]
- Correlation of functional parameters derived from Gd-EOB-DTPA enhanced MRI with ICG R15
- Correlation of functional and volumetric parameters derived from Gd-EOB-DTPA enhanced MRI
- Correlation of volumetric parameters derived from Gd-EOB-DTPA enhanced MRI and ICG15
- Comparison of functional MRI parameters between potential liver donors and patients undergoing hepatic resection for HCC.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01490203
|Korea, Republic of|
|Cheonnam University Hwasun Hospital|
|Hwasun-Gun, Cheonnam Province, Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of|
|The Catholic University of Korea, Seoul St. Mary's Hospital|
|Seoul, Korea, Republic of|
|Principal Investigator:||Jeong Min Lee, MD, PhD||Seoul National University Hospital|