title: 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: The 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.
  
  
  
  This 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.
  
  
  
  This 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.
  
  
  
  Clinicaltrials.gov identifier NCT02563158 . Registered on 28 September 2015.
authors.affiliation: Department of Hepatobiliary Surgery, Chinese People's Liberation Army General Hospital, 28 Fuxing Road, Haidian, Beijing, 100853, China.|Division of Transplantation, Department of Surgery, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, Boston, MA, 02114, USA.
authors.forename: Yinzhe
authors.initials: Y
authors.lastname: Xu
authors.affiliation: Department of Hepatobiliary Surgery, Chinese People's Liberation Army General Hospital, 28 Fuxing Road, Haidian, Beijing, 100853, China.
authors.forename: Jiye
authors.initials: J
authors.lastname: Chen
authors.affiliation: Department of Hepatobiliary Surgery, Chinese People's Liberation Army General Hospital, 28 Fuxing Road, Haidian, Beijing, 100853, China.
authors.forename: Hongguang
authors.initials: H
authors.lastname: Wang
authors.affiliation: Biostatistics Center, Massachusetts General Hospital, Harvard Medical School, 50 Staniford Street, Boston, MA, 02114, USA.
authors.forename: Hui
authors.initials: H
authors.lastname: Zheng
authors.affiliation: Division of Standard Operational Management, Institute of Hospital Management, Chinese PLA General Hospital, 28 Fuxing Road, Haidian, Beijing, 100853, China.
authors.forename: Dan
authors.initials: D
authors.lastname: Feng
authors.affiliation: Department of Hepatobiliary Surgery, Chinese People's Liberation Army General Hospital, 28 Fuxing Road, Haidian, Beijing, 100853, China.
authors.forename: Aiqun
authors.initials: A
authors.lastname: Zhang
authors.affiliation: Department of Hepatobiliary Surgery, Chinese People's Liberation Army General Hospital, 28 Fuxing Road, Haidian, Beijing, 100853, China.
authors.forename: Jianjun
authors.initials: J
authors.lastname: Leng
authors.affiliation: Department of Hepatobiliary Surgery, Chinese People's Liberation Army General Hospital, 28 Fuxing Road, Haidian, Beijing, 100853, China.
authors.forename: Weidong
authors.initials: W
authors.lastname: Duan
authors.affiliation: Department of Hepatobiliary Surgery, Chinese People's Liberation Army General Hospital, 28 Fuxing Road, Haidian, Beijing, 100853, China.
authors.forename: Zhanyu
authors.initials: Z
authors.lastname: Yang
authors.affiliation: Department of Hepatobiliary Surgery, Chinese People's Liberation Army General Hospital, 28 Fuxing Road, Haidian, Beijing, 100853, China.
authors.forename: Mingyi
authors.initials: M
authors.lastname: Chen
authors.affiliation: Department of Hepatobiliary Surgery, Chinese People's Liberation Army General Hospital, 28 Fuxing Road, Haidian, Beijing, 100853, China.
authors.forename: Xianjie
authors.initials: X
authors.lastname: Shi
authors.affiliation: Department of Hepatobiliary Surgery, Chinese People's Liberation Army General Hospital, 28 Fuxing Road, Haidian, Beijing, 100853, China.
authors.forename: Shouwang
authors.initials: S
authors.lastname: Cai
authors.affiliation: Department of Hepatobiliary Surgery, Chinese People's Liberation Army General Hospital, 28 Fuxing Road, Haidian, Beijing, 100853, China.
authors.forename: Wenbin
authors.initials: W
authors.lastname: Ji
authors.affiliation: Department of Hepatobiliary Surgery, Chinese People's Liberation Army General Hospital, 28 Fuxing Road, Haidian, Beijing, 100853, China.
authors.forename: Kai
authors.initials: K
authors.lastname: Jiang
authors.affiliation: Department of Hepatobiliary Surgery, Chinese People's Liberation Army General Hospital, 28 Fuxing Road, Haidian, Beijing, 100853, China.
authors.forename: Wenzhi
authors.initials: W
authors.lastname: Zhang
authors.affiliation: Department of Hepatobiliary Surgery, Chinese People's Liberation Army General Hospital, 28 Fuxing Road, Haidian, Beijing, 100853, China.
authors.forename: Yongliang
authors.initials: Y
authors.lastname: Chen
authors.affiliation: Department of Hepatobiliary Surgery, Chinese People's Liberation Army General Hospital, 28 Fuxing Road, Haidian, Beijing, 100853, China.
authors.forename: Wanqing
authors.initials: W
authors.lastname: Gu
authors.affiliation: Department of Hepatobiliary Surgery, Chinese People's Liberation Army General Hospital, 28 Fuxing Road, Haidian, Beijing, 100853, China.
authors.forename: Jiahong
authors.initials: J
authors.lastname: Dong
authors.affiliation: Department of Hepatobiliary Surgery, Chinese People's Liberation Army General Hospital, 28 Fuxing Road, Haidian, Beijing, 100853, China. lsc620213@aliyun.com.
authors.forename: Shichun
authors.initials: S
authors.lastname: Lu
mesh_terms: D006528:Carcinoma, Hepatocellular / Q000209:etiology / Q000601:surgery*; D002985:Clinical Protocols; D006498:Hepatectomy; D006509:Hepatitis B / Q000150:complications*; D006801:Humans; D008102:Liver Circulation; D008113:Liver Neoplasms / Q000209:etiology / Q000601:surgery*; D011446:Prospective Studies; D018401:Sample Size
keywords: Hepatocellular carcinoma; Inflammatory response; Ischemia-reperfusion injury; Liver resection; Randomized controlled trial; Survival; Vascular occlusion