Evaluation of Remnant Liver Function Using Primovist-enhanced MRI Before Resection/Ablation of Hepatocellular Carcinoma

Completed

• Conditions: Carcinoma, Hepatocellular; Liver Dysfunction
• Interventions: Drug: Gd-EOB-DTPA; Procedure: MRI

• Registration Number: NCT01490203
• Lead Sponsor: Seoul National University Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-07
• Study First Submitted QC: 2011-12-08
• Study First Posted: 2011-12-12
• Primary Completion: 2014-02
• Study Completion: 2016-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-22
• Last Update Posted: 2018-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1: HCC resection/RFA	MRI	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	Gd-EOB-DTPA	Potential liver donors with normal hepatic function and and underwent gadoxetic acid (Gd-EOB-DTPA)-enhanced MRI
Group 2: Potential liver donor	MRI	Potential liver donors with normal hepatic function and and underwent gadoxetic acid (Gd-EOB-DTPA)-enhanced MRI
Group 1: HCC resection/RFA	Gd-EOB-DTPA	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

Primary Outcome Measures

Name	Time	Method
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	3 days (upto 5 days) after surgery	Predicted RLF (HEF mL) = the sum of the individual HEF of each voxel in future remnant segment

Secondary Outcome Measures

Name	Time	Method
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	within 7 days before, and 3 to 5 days after surgery	1. 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).; 2. Volumetric parameters include global liver volume and remnant liver volume.; 3. Clinical liver function tests include ICG R15, MELD score and Child-Pugh score.; 4. 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	upto 3 months (plus minus 1 week) after discharge	1. 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; 2. Functional and volumetric MRI parameters of patients with postoperative complication and morbidity will be evaluated.; 3. Correlation of MRI parameters with laboratory liver function tests.
Exploratory analysis of MRI parameters and ICG R15 derived from potential liver donors	within 3 days of ICG R15 test	1. Correlation of functional parameters derived from Gd-EOB-DTPA enhanced MRI with ICG R15; 2. Correlation of functional and volumetric parameters derived from Gd-EOB-DTPA enhanced MRI; 3. Correlation of volumetric parameters derived from Gd-EOB-DTPA enhanced MRI and ICG15; 4. Comparison of functional MRI parameters between potential liver donors and patients undergoing hepatic resection for HCC.

Trial Locations

Locations (4)

Cheonnam University Hwasun Hospital; 🇰🇷 Hwasun-Gun, Cheonnam Province, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea, Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of