Ignite Creation Date:
2024-05-06 @ 3:12 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04559451
Status:
UNKNOWN
Last Update Posted:
2021-03-18
First Post:
2020-09-16
Brief Title:
Assessment of Remnant Liver Function in ALPPS by Gd-EOB-DTPA Enhanced MRI
Sponsor:
Peking University Third Hospital
Organization:
Peking University Third Hospital
Study Overview
Official Title:
Assessment of Remnant Liver Function in ALPPS by Gd-EOB-DTPA Enhanced MRI
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
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:
Insufficient future liver remnant FLR which may render post-hepatectomy liver failure is one of the major obstacles for performing liver resection for patients with liver malignants Associating liver partition and portal vein ligation ALPPS was introduced to induce rapid and extensive liver hypertrophy which offers the opportunity for removing the liver malignancy in the second stage operation for patients with insufficient FLR at their first stage operation Feasibility of the second stage of ALPPS has been assessed mostly on the basis of laboratory parameters and volumetry by the 3D reconstruction of CT Meanwhile part of the patients who underwent the second stage ALPPS still experienced postoperative liver failure even in patients with sufficient FLR volume In other words this volumetric increase may not reflect the increase of liver function And the laboratory parameters can only partly reflect the global liver function but not the regional liver function Therefore the combination of volumetric and global liver function tests might be unsuitable for predicting FLR function after first stage ALPPS because function is distributed unequally between left and right liver lobe The Gd-EOB-DTPA-enhanced liver MRI which has remarkable potential to evaluate regional liver function and could therefore be an ideal diagnostic test for performing volumetric and functional measurement after the first stage ALPPS in one examination Thus we performed this clinical trial in order to evaluate the efficacy of Gd-EOB-DTPA-enhanced liver MRI in evaluating the FLR liver function after the first stage ALPPS
Detailed Description:
The clinical data and follow up information of the patients who underwent laparoscopic ALPPS in Department of General Surgery Peking University Third Hospital were collected The indication for the performance of the first and second ALPPS was evaluated by multi-disciplinary team MDT The liver function evaluation indexes of Gd-EOB-DTPA Enhanced liver MRI such as RE Relative enhancement of the liverSI20min-SIunenhanced SIunenhanced and other related indexes were calculated SI referred to signal intensity SI20 min referred to the signal intensity in the hepatocyte phase 20 min after the injection The relationship between the indexes and postoperative liver failure as well as other complications were analyzed
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