Locally Advanced Malignant Liver Disease Clinical Trial
Official title:
Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS): Safety, Feasibility and Efficacy at a Single Center
The possibility to achieve a curative resection in patients with liver malignancies is limited by the future liver remnant (FLR). The Associating Liver Partition and Portal vein ligation for Staged hepatectomy (ALPPS) approach has recently been introduced as a revolutionary strategy to achieve resectability by inducing a rapid and large FLR hypertrophy. However, the possibility of achieving a short-term hypertrophy and high resectability rates has been counteracted in most published series by an increased risk of morbidity and mortality.The aim of this study was to evaluate the results with the ALPPS procedure in a single high-volume HPB center, with special emphasis in the safety and feasibility of this new 2-stage strategy. The aim of the present study was to assess the safety, feasibility and efficacy of ALPPS in a single high-volume hepatobiliary center.
Complete resection of liver malignancies remains as the best treatment to offer the
possibility of long-term survival or cure. At diagnosis, many patients have locally advanced
disease that often precludes a curative resection. During the past two decades, a better
assessment of resectability through modern imaging techniques along with new multimodal
therapies and the introduction of modern chemotherapy regimens have allowed to increase the
pool of candidates for surgical treatment in patients with locally advanced disease. The
current principles for safe liver resections focus mainly on the liver parenchyma that
remains after resection rather than the liver resected. In fact, one of the main conditioning
factors of posthepatectomy liver failure (PHLF) is the amount and quality of future liver
remnant (FLR). The induction of hypertrophy of healthy parenchyma using either portal vein
embolization (PVE) or ligation (PVL), in the setting of 1-stage or 2-stage liver resections,
is nowadays considered the standard of care for patients with locally advanced liver tumors
and small FLR.2,5-8 However, the need for long intervals between interventions (6-12 weeks),
results in resectability rates that rarely exceed 60-80%.
In 2012, Schnitbauer et al introduced a novel 2-stage technique that allowed tumor resection
in 25 patients from 5 German centers with marginally resectable or primarily nonresectable
disease by means of a rapid and large FLR hypertrophy. This technique was later popularized
with the acronym ALPPS for "Associating Liver Partition and Portal Vein Ligation for Staged
Hepatectomy". The promising preliminary results obtained with this new surgical proposal in
terms of hypertrophy and the possibility of challenging the previous methods generated a
pronounced reaction in the surgical community world-wide that has rarely been seen in the
history of hepato-pancreato-biliary (HPB) surgery. However, the possibility of achieving a
short-term hypertrophy and high resectability rates has been counteracted in most published
series by an increased risk of morbidity and mortality. The aim of this study was to evaluate
the results with the ALPPS procedure in a single high-volume HPB center, with special
emphasis in the safety and feasibility of this new 2-stage strategy.
Data for all patients undergoing 2-stage hepatectomies with the ALPPS approach at the HPB
Surgery Section of the Hospital Italiano de Buenos Aires between June 2011 and April 2014 was
analyzed on an intention to treat basis. Patient demographics, clinical characteristics (body
mass index, anesthesiological risk score, Charlson comorbidity index, preoperative
chemotherapy), tumor type, surgical details, FLR hypertrophy, postoperative liver function,
postoperative complications, length of hospital stay and survival were analyzed.
Regarding the surgical procedure, during the first stage a complete tumor resection
(clean-up) of the FLR is performed if bilateral disease was present, either trough anatomical
or atypical resections. Subsequently, the portal vein of the diseased hemi-liver (DH) is
divided and either total (up to the inferior vena cava) or partial (up to the middle hepatic
vein) parenchymal transection using the Cavitron Ultrasonic Surgical Aspirator (CUSA; Valley
Lab, Boulder, CO, USA) is carried out. At the end of the first stage, the DH is either
wrapped in a plastic bag or a plastic sheath placed between the cut surfaces. Once volumetric
CT analysis demonstrated enough FLR hypertrophy and provided the patient is in good
condition, the second stage is carried out the next available operative day resecting the DH.
The type of liver resections performed were defined using the Brisbane 2000 nomenclature.
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