Perioperative and long-term outcomes of liver resection for hepatitis B virus-related hepatocellular carcinoma without versus with hepatic inflow occlusion: study protocol for a prospective randomized controlled trial

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.

Does the intermittent Pringle maneuver affect the recurrence following surgical resection for hepatocellular carcinoma? A systematic review

“…Concerns on recurrence resulted from IPM have always been hovering in the heads of hepatobiliary surgeons [17,18]. This was the first systematic review, which was designed to evaluate the effect of IPM on the long-term outcomes and recurrence.…”

“…Intermittent pringle maneuver (IPM) is the most common kind of blood occlusion worldwide, mainly because it would reduce the risk of I/R when compared with PM [14,15], which is confirmed in the animal model [16]. However, worries about recurrence correlated with IPM never lessens [17,18].…”