Ignite Creation Date:
2024-05-06 @ 2:57 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02164292
Status:
COMPLETED
Last Update Posted:
2019-08-13
First Post:
2014-06-11
Brief Title:
ALPPS Safety Feasibility and Efficacy at a Single Center
Sponsor:
Hospital Italiano de Buenos Aires
Organization:
Hospital Italiano de Buenos Aires
Study Overview
Official Title:
Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy ALPPS Safety Feasibility and Efficacy at a Single Center
Status:
COMPLETED
Status Verified Date:
2019-08
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:
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 mortalityThe 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
Detailed Description:
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 FLR25-8 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
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
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