Abstract
BackgroundThe high prevalence of hepatitis B virus (HBV) imposes a huge burden of hepatocellular carcinoma (HCC) in Asia. Surgical resection remains an important therapeutic strategy for HCC. Hepatic inflow occlusion, known as the Pringle maneuver, is the most commonly used method of reducing blood loss during liver parenchymal transection. A major issue with this maneuver is ischemia-reperfusion injury to the remnant liver, and the hemodynamic disturbance it induces in the tumor-bearing liver raises an oncological concern. Given the technical advances in living donor liver transplantation, vascular occlusion in liver resection can be avoided in experienced hands. The aim of this study is to compare the perioperative and long-term outcomes of liver resection for HBV-related HCC without versus with hepatic inflow occlusion.Methods/designThis study will include eligible patients with HBV-related HCC elected for liver resection. Fifty-seven patients will be enrolled in each randomization arm to detect a 20 % difference in the serum level of total bilirubin on postoperative day 5 (80 % power and α = 0.05). The secondary endpoints include procedural parameters, perioperative liver function and inflammatory response, postoperative morbidity and mortality, and long-term outcomes. Patients will be followed for up to 5 years. Data will be statistically analyzed on an intention-to-treat basis.DiscussionThis prospective randomized controlled trial is designed to compare the perioperative and long-term outcomes of liver resection for HBV-related HCC without versus with vascular occlusion. The clinical implications of these outcomes may change current surgical practice and fill the oncological gaps therein.Trial registrationClinicaltrials.gov identifier NCT02563158. Registered on 28 September 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1621-9) contains supplementary material, which is available to authorized users.
Highlights
The high prevalence of hepatitis B virus (HBV) imposes a huge burden of hepatocellular carcinoma (HCC) in Asia
In China, HCC is the second most common cause of cancer-related death [2], and up to 80 % of HCC cases are attributable to hepatitis B virus (HBV) infection [3, 4]
Trial population From January 2016 to November 2017, all patients with HBV-related HCC scheduled for elective partial hepatectomy in the Department of Hepatobiliary magnetic resonance imaging (MRI) Magnetic resonance imaging (Surgery), Chinese People’s Liberation Army General Hospital (PLAGH), will be screened for eligibility for this trial
Summary
The high prevalence of hepatitis B virus (HBV) imposes a huge burden of hepatocellular carcinoma (HCC) in Asia. Known as the Pringle maneuver, is the most commonly used method of reducing blood loss during liver parenchymal transection. A major issue with this maneuver is ischemia-reperfusion injury to the remnant liver, and the hemodynamic disturbance it induces in the tumor-bearing liver raises an oncological concern. Known as the Pringle maneuver, is traditionally practiced to reduce blood loss during liver parenchymal transection [7]. This maneuver induces significant ischemia-reperfusion (IR) injury to the remnant liver, especially in patients with underlying liver disease [8]. Intermittent application of the Pringle maneuver, a recommended practice, could induce hemodynamic disturbance to the tumor-bearing liver, which raises an oncological concern [13, 14]
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