Ignite Creation Date:
2024-05-06 @ 8:53 AM
Last Modification Date:
2024-10-26 @ 12:06 PM
Study NCT ID:
NCT02846441
Status:
COMPLETED
Last Update Posted:
2016-07-28
First Post:
2016-07-22
Brief Title:
Interstage Assessment of Remnant Liver Function in ALPPS
Sponsor:
Hospital Italiano de Buenos Aires
Organization:
Hospital Italiano de Buenos Aires
Study Overview
Official Title:
Interstage Assessment of Remnant Liver Function in ALPPS Can SPECT Hepatobiliary Scintigraphy Provide Any Additional Value in Predicting Risk of Posthepatectomy Liver Failure
Status:
COMPLETED
Status Verified Date:
2016-07
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:
Post-hepatectomy liver failure is one of the most feared complications by hepatic surgeons When size of the future liver remnant FLR is regarded to be not sufficient to sustain post-hepatectomy liver function techniques as preoperative portal vein embolization or two-stage hepatectomyassociating liver partition and portal vein ligation ALPPS can be performed ALPPS induces rapid and extensive hypertrophy by portal vein ligation and in situ liver splitting To date feasibility of the second stage of ALPPS has been assessed only on the basis of standardized future liver remnant or future liver remnant on body weight However decrease of liver function between stages measured by means of laboratory parameters has been demonstrated to be associated with higher 90-day mortality regardless of FLR volume In other words this volumetric increase may not reflect the increase of liver function
Detailed Description:
The aim of this study is to determine the predictive value of hepatobiliary scintigraphy with 99mTc-mebrofenin between stages in ALPPS in assessing risk of postoperative liver failure and liver failure-related mortality after completion of stage 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None