Ignite Creation Date:
2024-05-06 @ 3:09 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02215577
Status:
UNKNOWN
Last Update Posted:
2014-08-13
First Post:
2014-08-11
Brief Title:
ALPPS Versus PVEPL
Sponsor:
Regionalt Cancercentrum Väst
Organization:
Regionalt Cancercentrum Väst
Study Overview
Official Title:
Comparison of Two Different Models of Liver Growth Stimulation in Advanced Colorectal Liver Metastatic Disease LIGRO Trial Enabling Liver Resection
Status:
UNKNOWN
Status Verified Date:
2014-08
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:
LIGRO
Brief Summary:
Study Title Comparison of two different models of liver growth stimulation in advanced colorectal liver metastatic disease LIGRO Trial enabling liver resection
Methodology Scandinavian Multiple Center Randomized Registry Based Clinical Trial
Study duration The planned duration of study participation for an individual subject from inclusion to follow-up are 3 years
Primary investigator
Per Sandstrom Linköping
Number of subjects 100 patients randomized in a 11 randomization
Diagnosis and main inclusion criteria Patients with colorectal liver metastasis requiring liver resection but are not resectable in one step because of a future liver remnantstandardized total liver volume of 30 extrahepatic metastatic disease is not an exclusion criteria if they can be addressed surgically in the future
Overall goal To evaluate if the ALPPS approach is superior to PVE in enabling patients primarily unresectable due to inadequate FLR to be resected and reach an R0 situation with an acceptable level of complications and perioperative mortality
To evaluate if the ALPPS approach increases the growth rate of the liver compared to portal embolization or portal ligation leading to a shorter treatment period
In addition the investigators aim to study if ALPPS may reach these goals without detectable or improved differences in tumor activity PFS and OS but with a shorter recovery and a higher proportion of patients reaching R0
Hypothesis A higher proportion of patients can be resected with ALPPS counted as rate resected compared to the previously established methods with portal ligation or embolization
This increased resection rate will not reduce the R0 rate or increase the rate of Clavien grade 4 complication or higher H0
The ALPPS approach will increase the growth rate compared to portal embolizationligation measured one week after the primary intervention
Methodology Scandinavian Multiple Center Randomized Registry Based Clinical Trial
Study duration The planned duration of study participation for an individual subject from inclusion to follow-up are 3 years
Primary investigator
Per Sandstrom Linköping
Number of subjects 100 patients randomized in a 11 randomization
Diagnosis and main inclusion criteria Patients with colorectal liver metastasis requiring liver resection but are not resectable in one step because of a future liver remnantstandardized total liver volume of 30 extrahepatic metastatic disease is not an exclusion criteria if they can be addressed surgically in the future
Overall goal To evaluate if the ALPPS approach is superior to PVE in enabling patients primarily unresectable due to inadequate FLR to be resected and reach an R0 situation with an acceptable level of complications and perioperative mortality
To evaluate if the ALPPS approach increases the growth rate of the liver compared to portal embolization or portal ligation leading to a shorter treatment period
In addition the investigators aim to study if ALPPS may reach these goals without detectable or improved differences in tumor activity PFS and OS but with a shorter recovery and a higher proportion of patients reaching R0
Hypothesis A higher proportion of patients can be resected with ALPPS counted as rate resected compared to the previously established methods with portal ligation or embolization
This increased resection rate will not reduce the R0 rate or increase the rate of Clavien grade 4 complication or higher H0
The ALPPS approach will increase the growth rate compared to portal embolizationligation measured one week after the primary intervention
Detailed Description:
None
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