ALPPS versus PVO (USZ-ZH-VIS-ALPPS)
Research type
Research Study
Full title
Associating Liver Partition with Portal Vein Ligation for Staged Hepatectomy (ALPPS) versus ConventionalPortal Vein Occlusion (PVO)to induce liver regeneration for resection of liver tumors that are unresectable in one step – a randomized controlled trial.
IRAS ID
127618
Contact name
Massimo Malago
Contact email
Sponsor organisation
University College London
Research summary
The study is based in patients who have cancer involving both liver lobes, which is either too large to remove in one step or the risks are too high to advocate removal in one step. The standard therapy in this situation is a staged operation in two steps. This involves occluding one side of the portal vein, allowing the other part of the liver to grow and then removing the side with the occluded portal vein after 6-8 weeks. However, during this waiting time period the tumors may grow or spread and therefore not all patients are able to undergo the second step of the procedure.
There is now another alternative in which the diseased part of the liver can be removed in 1-2 weeks. This can be done by adding a division of the liver tissue between the lobe that will remain, and the one that has been deportalized (ALPPS). We know the liver seems to grow faster with the new technique and during the shorter wating time period the tumors are unlikely to grow significanty or spread. However, it is not clear whether this new ALPPS technique is superior to the conventional method with 6-8 weeks between the steps. This study will compare these two surgical techniques.
The new method (ALPPS) has the potential to replace the old method. Mid-term goal of both strategies is tumor-free patient. The advantages and disadvantages of both strategies are unclear in respect to this objective. As long as both surgical procedures function equally well and are being performed by surgeons around the world, we believe that a clinical trial of these two techniques is warranted. Preliminary data has suggested that ALPPS is a better approach in terms of achieving the goal of tumor free liver, overall survival and quality of life.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
13/SC/0365
Date of REC Opinion
11 Nov 2013
REC opinion
Further Information Favourable Opinion