Status:
COMPLETED
Evaluation of Remnant Liver Function Using Primovist-enhanced MRI Before Resection/Ablation of Hepatocellular Carcinoma
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Bayer
Seoul St. Mary's Hospital
Conditions:
Carcinoma, Hepatocellular
Liver Dysfunction
Eligibility:
All Genders
18+ years
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 re...
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 live...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT01490203
Start Date
December 1 2011
End Date
December 1 2016
Last Update
March 23 2018
Active Locations (4)
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1
Cheonnam University Hwasun Hospital
Hwasun-Gun, Cheonnam Province, South Korea
2
Asan Medical Center
Seoul, South Korea
3
Seoul National University Hospital
Seoul, South Korea
4
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea