Surgery Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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