Background and Aims: In liver transplantation, cold preservation induces ischemia, resulting in significant reperfusion injury. Hypothermic oxygenated machine perfusion (HMP-O₂) has shown benefits compared to static cold storage (SCS) by limiting ischemia-reperfusion injury. This study reports outcomes using a novel portable HMP-O₂ device in the first US randomized control trial. Approach and Results: The PILOT trial (NCT03484455) was a multicenter, randomized, open-label, noninferiority trial, with participants randomized to HMP-O₂ or SCS. HMP-O₂ livers were preserved using the Lifeport Liver Transporter and Vasosol perfusion solution. The primary outcome was early allograft dysfunction. Noninferiority margin was 7.5%. From April 3, 2019, to July 12, 2022, 179 patients were randomized to HMP-O₂ (n=90) or SCS (n=89). The per-protocol cohort included 63 HMP-O₂ and 73 SCS. Early allograft dysfunction occurred in 11.1% HMP-O₂ (N=7) and 16.4% SCS (N=12). The risk difference between HMP-O₂ and SCS was −5.33% (one-sided 95% upper confidence limit of 5.81%), establishing noninferiority. The risk of graft failure as predicted by Liver Graft Assessment Following Transplant score at seven days (L-GrAFT₇) was lower with HMP-O₂ [median (IQR) 3.4% (2.4–6.5) vs. 4.5% (2.9–9.4), p=0.024]. Primary nonfunction occurred in 2.2% of all SCS (n=3, p=0.10). Biliary strictures occurred in 16.4% SCS (n=12) and 6.3% (n=4) HMP-O₂ (p=0.18). Nonanastomotic biliary strictures occurred only in SCS (n=4). Conclusions: HMP-O₂ demonstrates safety and noninferior efficacy for liver graft preservation in comparison to SCS. Early allograft failure by L-GrAFT₇ was lower in HMP-O₂, suggesting improved early clinical function. Recipients of HMP-O₂ livers also demonstrated a lower incidence of primary nonfunction and biliary strictures, although this difference did not reach significance.

Intrahepatic cholangiocarcinoma (iCCA) is a rare and complex malignancy of the biliary epithelium. Due to its silent presentation, patients are frequently diagnosed late in their disease course, resulting in poor overall survival. Advances in molecular profiling and targeted therapies have improved medical management, but long-term survival is rarely seen with medical therapy alone. Surgical resection offers a survival advantage, but negative oncologic margins are difficult to achieve, recurrence rates are high, and the need for adequate future liver remnant limits the extent of resection. Advances in neoadjuvant and adjuvant treatments have broadened patient treatment options, and these agents are undergoing active investigation, especially in the setting of advanced, initially unresectable disease. For those who are not able to undergo resection, liver transplantation is emerging as a potential curative therapy in certain cases. Patient selection, favorable tumor biology, and a protocolized, multidisciplinary approach are ultimately necessary for best patient outcomes. This review will discuss the current surgical management of locally advanced, liver-limited intrahepatic cholangiocarcinoma as well as the role of liver transplantation for select patients with background liver disease.

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