ARAPS Study: Comparison of Portal Vein Embolization With Radiofrequency Ablation Versus Portal Vein Embolization Alone for Accelerated Liver Regeneration: A Randomized Controlled Trial

Curative intent liver resection is the gold standard for treatment of hepatic malignancies, including metastases from colorectal cancer (CRLM), but liver resection can only be performed if future liver remnant (FLR) volume is at least 25 %. Unfortunately, many cancer patients have multiple liver lesions at the time of diagnosis, rendering radical resection impossible due to a marginal FLR, thereby increasing the risk of posthepatectomy liver failure and subsequent death.

Several techniques have been designed to increase the size of the FLR, allowing more patients to undergo surgery. These techniques include portal vein embolization (PVE), portal vein ligation (PVL), two-stage partial hepatectomy, and the associating liver partition with PVL for staged hepatectomy (ALPPS). The ALPPS procedure seems to be superior to the other techniques for achieving increased size and accelerated growth of the FLR. Especially the kinetic growth rate (KGR) is superior to what has been previously described. The major drawback of ALPPS is, however, that the patient is subjected to two open procedures that are associated with high morbidity and mortality.

In a previous experimental study on rats, The investigators have shown that PVE combined with radiofrequency ablation (RFA), hereafter called Associated Radiofrequency Ablation and Portal Vein Ligation for Staged Hepatectomy (ARAPS), can induce accelerated growth of the FLR as potent as that seen after ALPPS. In humans, the ARAPS procedure can (the first step), in contrast to the two-stage ALPPS procedure, be performed percutaneously, and the investigators expect this to reduce the high morbidity and mortality associated with the ALPPS. In the present study, the investigators want to examine the effect of ARAPS compared with PVE alone on liver regeneration and function of the FLR.

Study rationale In order to allow more patients to undergo radical surgery for CRLM, implementation of new methods to enhance liver regeneration is vital.

Aim In the present study, the investigators test the hypothesis that the ARAPS approach is superior to PVE alone in achieving growth of the FLR in patients with CRLM.