Gd-EOB-DTPA-enhanced T1 Map for Predicting Postoperative Liver Failure

Comparing the Value of the Circular Region-of-interest- and Whole-liver Histogram-based Analysis on Gd-EOB-DTPA-enhanced T1 Map for Predicting Postoperative Liver Failure

Researchers designed this study to compare the value of the conventional circular region-of-interest (ROI) and whole-liver histogram-based analysis on gadoxetic acid disodium (Gd-EOB-DTPA)-enhanced T1 map for predicting postoperative liver failure (PHLF). Researchers collected and analyzed the data of patients who underwent partial hepatectomy for focal liver lesions. Researchers drew circular ROIs on Gd-EOB-DTPA-enhanced T1 maps to get the mean T1 values. Researchers used a multiparametric analysis software to get histogram parameters. Then researchers compared the differences of these parameters between the PHLF group and non-PHLF group.

Study Overview

• Status: Completed
• Conditions: Liver Failure
• Intervention / Treatment: Diagnostic test: T1 mapping on gadoxetic acid-enhanced MRI

Detailed Description

The objective of this study is to compare the value of the circular region-of-interest (ROI) and whole-liver histogram-based analysis on gadoxetic acid disodium (Gd-EOB-DTPA)-enhanced T1 map for predicting postoperative liver failure. Forty patients who underwent partial hepatectomy for focal liver lesions were retrospectively analyzed. All subjects underwent 1.5T Gd-EOB-DTPA-enhanced MRI including pre-contrast and hepatobiliary-phase T1 mapping. Patients were divided into two groups with (16 patients) and without (24 patients) postoperative liver failure according to the criteria established by the International Study Group for Liver Surgery (ISGLS). T1 values before enhancement (T1pre) and in the hepatobiliary phase (T1HBP) were measured by outlining a circular ROI on the axial T1 maps. The reduction rate of T1 relaxation time (rrT1) = (T1 pre - T1HBP) / T1 pre. The whole-liver histogram analysis was performed using the prototype MR Multiparametric Analysis software (Siemens Healthcare, Erlangen, Germany). Differences of the circular ROI-based mean values and the histogram parameters between the two groups were compared. The receiver operating characteristic curve (ROC) was plotted. The circular ROI-based mean values and the histogram parameters for predicting PHLF was assessed by the area under the curve (AUC).

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

the study group comprised 40 patients with an age range of 28 - 83 years (mean age, 58 years).

Description

Inclusion Criteria:

1. underwent liver resection; 2. underwent gadoxetic acid-enhanced MRI including, T1 mapping before and 20 minutes after gadoxetic acid administration within four weeks before the surgery ; 3. had an international normalized ratio (INR) and bilirubin examination on or after postoperative day five.

Exclusion Criteria:

1. patients who had undergone non-resection treatment, including chemotherapy, radiofrequency ablation, percutaneous ethanol injection, or transarterial chemoembolization; 2. patients whose images had severe respiratory motion artifacts.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PHLF group and non-PHLF group; group with and without PHLF	Diagnostic test: T1 mapping on gadoxetic acid-enhanced MRI; All subjects underwent 1.5T Gd-EOB-DTPA-enhanced MRI including pre-contrast and hepatobiliary-phase T1 mapping.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative liver failure	increased INR and concomitant hyperbilirubinemia, according to the normal cut-off levels defined by the local laboratory on or after postoperative day five	March, 2016- March, 2018

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2021
• Primary Completion (Actual): December 20, 2021
• Study Completion (Actual): October 13, 2022

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: October 20, 2022
• First Posted (Actual): October 24, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 20, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: magnetic resonance imaging; liver failure; Gd-EOB-DTPA; hepatectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure; Hepatic Insufficiency
• Other Study ID Numbers: B2021-271

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No