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

NCT05592106 | Completed DMC

• 1 other identifier: B2021-271
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Failure

Keywords

Gd-EOB-DTPA; hepatectomy; liver failure; magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

PHLF group and non-PHLF group

group with and without PHLF

Diagnostic Test: T1 mapping on gadoxetic acid-enhanced MRI

Interventions

T1 mapping on gadoxetic acid-enhanced MRI DIAGNOSTIC_TEST

All subjects underwent 1.5T Gd-EOB-DTPA-enhanced MRI including pre-contrast and hepatobiliary-phase T1 mapping.

PHLF group and non-PHLF group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Liver Failure

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 24, 2022
• Study Start: October 10, 2021
• Primary Completion: December 20, 2021
• Study Completion: October 13, 2022
• Last Updated: October 24, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)