Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06181318
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-26
First Post:
2023-12-12
Brief Title:
Quantitative MRI and Outcomes of Liver Resection
Sponsor:
University Hospital Heidelberg
Organization:
University Hospital Heidelberg
Study Overview
Official Title:
Predicting the Outcomes of LIVEr Resection Using Quantitative Magnetic Resonance Imaging the POLIVER Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present observational study aims to assess the benefit of this quantitative multiparametric magnetic resonance imaging MRI in clinical practice to quantify future liver remnant performance and to accurately predict the risk of liver failure after major hepatectomy among patients undergoing major liver resection
The main questions to be answered are
Can multiparametric MRI predict the postoperative liver function
Can multiparametric MRI predict the postoperative liver-specific complications as well as mortality With ethical approval and fully informed consent patients being considered for major liver resection will undergo clinical assessment blood sampling and multiparametric MRI before surgery For the primary outcome 33 participants will be needed to detect a minimum correlation coefficient of 02 with 5 significance and 80 power
The main questions to be answered are
Can multiparametric MRI predict the postoperative liver function
Can multiparametric MRI predict the postoperative liver-specific complications as well as mortality With ethical approval and fully informed consent patients being considered for major liver resection will undergo clinical assessment blood sampling and multiparametric MRI before surgery For the primary outcome 33 participants will be needed to detect a minimum correlation coefficient of 02 with 5 significance and 80 power
Detailed Description:
In patients being considered for major liver resection volumetric and functional evaluation of the future liver remnant should ideally be combined to reduce the risk of posthepatectomy liver failure PHLF and other adverse outcomes Quantitative multiparametric magnetic resonance imaging MRI can measure liver health by assessing parenchyma fibrosis and inflammation This has shown promising results in predicting postoperative liver performance The current study aims to assess the benefit of this MRI-based technology in clinical practice to quantify future liver remnant performance and to accurately predict the risk of liver failure after major hepatectomy
Prospective observational clinical study in a single hepatobiliary surgery center With ethical approval and fully informed consent patients being considered for major liver resection will undergo clinical assessment blood sampling and multiparametric MRI before surgery Postoperative liver function and complications will be reported for 90 days after surgery Preoperative MRI assessment scores and postoperative outcomes will be correlated to determine whether multiparametric MRI scans can accurately predict the risk of postoperative liver-specific complications primary endpoint as well as postoperative liver function surgery-specific complications the overall complication rate quality of hospital care and length of stay For the primary outcome 33 participants will be needed to detect a minimum correlation coefficient of 02 with 5 significance and 80 power This study will include 33 patients and results are expected in 2024 If successful this investigation will support the use of quantitative multiparametric MRI to guide surgical decision-making This will represent a non-invasive diagnostic volumetric and segmental functional test for the preoperative workup of patients being considered for major hepatectomy
Prospective observational clinical study in a single hepatobiliary surgery center With ethical approval and fully informed consent patients being considered for major liver resection will undergo clinical assessment blood sampling and multiparametric MRI before surgery Postoperative liver function and complications will be reported for 90 days after surgery Preoperative MRI assessment scores and postoperative outcomes will be correlated to determine whether multiparametric MRI scans can accurately predict the risk of postoperative liver-specific complications primary endpoint as well as postoperative liver function surgery-specific complications the overall complication rate quality of hospital care and length of stay For the primary outcome 33 participants will be needed to detect a minimum correlation coefficient of 02 with 5 significance and 80 power This study will include 33 patients and results are expected in 2024 If successful this investigation will support the use of quantitative multiparametric MRI to guide surgical decision-making This will represent a non-invasive diagnostic volumetric and segmental functional test for the preoperative workup of patients being considered for major hepatectomy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None