Liver FailureNCT05592106
Gd-EOB-DTPA-enhanced T1 Map for Predicting Postoperative Liver Failure
An observational study of Liver Failure, run by Shanghai Zhongshan Hospital at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Liver Failure
- What is being tested?
- T1 mapping on gadoxetic acid-enhanced MRI
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2021to 13 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the study group comprised 40 patients with an age range of 28 - 83 years (mean age, 58 years).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
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
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.
Read the 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).
- Conditions
- Liver Failure
- Being tested
- T1 mapping on gadoxetic acid-enhanced MRI
- Keywords
- Gd-EOB-DTPA, hepatectomy, liver failure, magnetic resonance imaging
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T1 mapping on gadoxetic acid-enhanced MRIDiagnostic test
All subjects underwent 1.5T Gd-EOB-DTPA-enhanced MRI including pre-contrast and hepatobiliary-phase T1 mapping.
| Study group | Role | What they receive |
|---|---|---|
| PHLF group and non-PHLF group | group with and without PHLF Receives: Diagnostic Test: T1 mapping on gadoxetic acid-enhanced MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: March, 2016- March, 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start10 Oct 2021
- Primary completion20 Dec 2021
- Study completion13 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592106
- Sponsor's protocol ID
- B2021-271
- Status last verified
- Oct 2022
- First submitted
- 20 Oct 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05592106
- Acronym / sponsor ID
- B2021-271
- Conditions
- Liver Failure
- Keywords
- Gd-EOB-DTPA, hepatectomy, liver failure, magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 13 Oct 2022 (actual)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PHLF group and non-PHLF group | – | Diagnostic Test: T1 mapping on gadoxetic acid-enhanced MRIgroup with and without PHLF |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the study group comprised 40 patients with an age range of 28 - 83 years (mean age, 58 years).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T1 mapping on gadoxetic acid-enhanced MRIAll subjects underwent 1.5T Gd-EOB-DTPA-enhanced MRI including pre-contrast and hepatobiliary-phase T1 mapping. | Diagnostic test | PHLF group and non-PHLF group |
Primary outcome
postoperative liver failure
Time frame: March, 2016- March, 2018
increased INR and concomitant hyperbilirubinemia, according to the normal cut-off levels defined by the local laboratory on or after postoperative day five
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Failure, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative liver failure (time frame: March, 2016- March, 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022.