Ignite Creation Date:
2024-05-06 @ 8:29 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02758977
Status:
UNKNOWN
Last Update Posted:
2016-05-03
First Post:
2016-04-05
Brief Title:
Associating Liver Partition With Portal Vein Ligation for Staged Hepatectomy ALPPS vs Two-Stage Hepatectomy TSH for Marginally Resectable Colorectal Liver Metastases CRLM
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Associating Liver Partition With Portal Vein Ligation for Staged Hepatectomy ALPPS vs Conventional Two-Stage Hepatectomy TSH for Surgical Treatment of Marginally Resectable Colorectal Liver Metastases CRLM - A Multicentric Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2016-04
Last Known Status:
NOT_YET_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:
ALPPSforCRLM
Brief Summary:
Surgical resection has offered the best option for prolonged survival in patients with colorectal liver metastases Limiting factor for major liver resections is the size of the future liver remnant FLR In case of normal liver function 30 of the total liver volume is considered to be sufficient to maintain adequate liver function after resection In an attempt to further increase resectability criteria for patients with too small FLR surgical and interventional maneuvers such as portal vein embolization and portal vein ligation in two-stage hepatectomies have been implemented but they need an interval of 4-8 weeks to achieve sufficient hypertrophy In order to obtain adequate but rapid parenchymal hypertrophy a new surgical two-step technique ALPPS was introduced for oncological patients requiring extended hepatic resection with limited functional reserve Both procedures can be performed with acceptable morbidity and mortality
The investigators conclude that it is time to perform a randomized study comparing the two surgical approaches in regard to oncological outcome
The investigators conclude that it is time to perform a randomized study comparing the two surgical approaches in regard to oncological outcome
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