We hypothesize that ALPPS enables R0 resection of liver tumors leading to small future liver remnants more effectively than the conventional two-staged approaches. ALLPS can be applied to all indications of the convetional procedures. We therefore propose a randomized controlled trial (RCT) in 80 patients undergoing surgery for primarily unresectable liver tumors, with 40 patients in the ALPPS arm and 40 patients in the conventional therapy arm. The sample size has been set to detect a significant difference between 70% of controls (conventional approach) and 95% of cases (ALPPS) in achieving complete resection of tumors within 3 months (as confirmed by pathology and MRI).
Inclusion criteria will be:
1. Patients with primary and/or secondary liver tumors and a size of the future liver remnant of less than 30% of the original volume after resection in MRI-based volumetric resection planning. Volumetric data will be corroborated by the liver–body weight ratio (LBWR), with 30% volume corresponding to a LBWR of 0.5%.
2. Patients with liver tumors and preexisting liver injury (fibrosis, steatosis, cholestasis sinusoidal obstruction syndrome due to chemotherapy) and a size of the future remnant of less than 40% original volume (LBWR 0.8%) in MRI-based volumetric resection planning.
3. Patients that are considered surgical candidates from an oncological standpoint, e.g. exclusion of extrahepatic metastases for most entities or with extrahepatic CRC metastases if clearly resectable.
Exclusion criteria involve
(1) significant comorbidities preventing major liver surgery,
(2) ECOG >1,
(3) need for major extrahepatic surgery (pancreatic, gastric, rectal resection) that may not be delayed for 3 months, and
(4) candidacy for liver transplantation to treat liver disease.
Expected results are that more than 90% of patients will proceed to final resection with the ALPPS approach as compared to 60% with the conventional approach. If this is confirmed, ALPPS should be considered the superior approach to liver resection in such cases, provided other outcomes being equal. If not, this study has to decline superiority of ALPPS over the conventional approach. Of note, no RCT on conventional two-staged hepatectomies has been performed.