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

Status Completed

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05592106
Study type	Observational
Source	Shanghai Zhongshan Hospital
Contact
Status	Completed
Phase
Start date	October 10, 2021
Completion date	October 13, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03791190` - RCA for CRRT in Liver Failure and High Risk Bleeding Patients	N/A
Recruiting	`NCT05989958` - The Safety and Tolerability Study of HepaCure in Chinese Subjects With Acute-On-Chronic Liver Failure	Phase 1
Completed	`NCT02557724` - Mobilization of Mesenchymal Stem Cells During Liver Transplantation
Recruiting	`NCT01698723` - A Trial of Ribavirin in Patients With ACLF Due to Hepatitis E Virus	Phase 2
Completed	`NCT01425385` - Autoregulation Assessment During Liver Transplantation	N/A
Completed	`NCT01404793` - SPME For Metabolomics And Concomitant Measurements Of Rocuronium Bromide Levels In Liver Transplantation	N/A
Completed	`NCT00808691` - Microcirculation and Oxidative Stress in Critical Ill Patients in Surgical Intensive Care Unit	N/A
Completed	`NCT03864497` - Myocardial Perfusion Imaging in Liver Transplantation Candidates
Completed	`NCT00287235` - Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS)	N/A
Completed	`NCT03650920` - Hepatitis C Virus (HCV) Positive Liver Grafts in HCV Negative Recipients	N/A
Recruiting	`NCT05517668` - Evaluation of the Efficacy of Fomepizole in the Treatment of Acetaminophen Overdose	Phase 2
Recruiting	`NCT05726032` - Empagliflozin in Patients With Cirrhosis and Ascites	Phase 2
Recruiting	`NCT04548596` - NOninVasive Intracranial prEssure From Transcranial doppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients
Recruiting	`NCT02331745` - RCT Study on Granulocyte Colony-stimulating Factor(G-CSF) Treatment of Hepatic Failure	Phase 4
Not yet recruiting	`NCT01961440` - Prognosis Scoring System for Acute-on-Chronic Liver Failure	N/A
Active, not recruiting	`NCT01221454` - Allogenic Bone Marrow Stem Cell Transplantation in Liver Failure	Phase 2
Completed	`NCT00772148` - Pharmacokinetics of LCP-Tacro™ Once Daily and Prograf® Twice A Day in Adult De Novo Liver Transplant Patients	Phase 2
Not yet recruiting	`NCT06014320` - Alterations in Coagulation Factor Levels in Patients With End Stage Liver Disease
Recruiting	`NCT04221672` - The Effect of Terlipressin on Recovery of Liver Function After Hepatectomy	Phase 3
Completed	`NCT02635347` - Remote Ischemic Conditioning (RIC) in Recipients of Brain Death Donor Livers - A Feasibility and Safety Study	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.