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

Liver Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05592106
• Other study ID #: B2021-271
• Status: Completed
• Start date: October 10, 2021
• Est. completion date: October 13, 2022

Study information

• Verified date: October 2022
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 13, 2022
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatic Insufficiency
• Liver Failure

Intervention

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.

Locations

Country	Name	City	State
China	Zhongshan Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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