BiClamp® forcep liver transection versus clamp crushing technique for liver resection: study protocol for a randomized controlled trial.
BACKGROUND
Blood loss and the requirement of blood transfusions during liver transection have been shown to correlate well with higher morbidity and mortality rates and a worse prognosis. Various devices for liver parenchymal transection have been developed to reduce intraoperative blood loss. The goal of this study is to evaluate the safety and effectiveness of BiClamp® forcep transection compared to a clamp crushing technique in patients undergoing liver resection.


METHODS
This study will include patients 18 years and older scheduled for hepatectomy with hepatic vascular exclusion who give informed consent. A sample size of 48 patients in each randomization arm will be calculated to detect a difference in the reduction of blood loss of approximately 200 ml (90% power and α = 0.05 (two-tailed)). The primary efficacy endpoint of the trial will be the total intraoperative blood loss based on the randomized dissection technique. The statistical analysis is based on the intention-to-treat population. Patients will be followed up on for three months for complications and adverse events.


CONCLUSIONS
This prospective, single-center, randomized controlled, single-blinded, two-group parallel trial is designed to assess the efficacy and safety of BiClamp forcep hepatectomy versus clamp crushing for parenchymal transection during elective hepatic resection.


BACKGROUND
This trial was registered with Clinicaltrials.gov (identifier: NCT02197481 ) on 15 July 2014.
Department of Surgery, The Second Affiliated Hospital of Anhui Medical University, No. 678 Furong Road, Shushan District, , Anhui, Hefei, 230022, China. chenjm10@126.com.
Jiang-ming
JM
Chen
Department of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, No. 1630 Dongfang Road, Shanghai, 200127, China. gengwei1999@hotmail.com.
Wei
W
Geng
Department of Surgery, The First Affiliated Hospital of Anhui Medical University, No. 218 Jixi Road, Shushan District, , Anhui, Hefei, 230022, China. liufubao@163.com.
Fu-bao
FB
Liu
Department of Surgery, The First Affiliated Hospital of Anhui Medical University, No. 218 Jixi Road, Shushan District, , Anhui, Hefei, 230022, China. zhc0117@sina.com.
Hong-chuan
HC
Zhao
Department of Surgery, The Second Affiliated Hospital of Anhui Medical University, No. 678 Furong Road, Shushan District, , Anhui, Hefei, 230022, China. xshx2000@hotmail.com.
Sheng-xue
SX
Xie
Department of Surgery, The Second Affiliated Hospital of Anhui Medical University, No. 678 Furong Road, Shushan District, , Anhui, Hefei, 230022, China. hui0402@hotmail.com.
Hui
H
Hou
Department of Surgery, The First Affiliated Hospital of Anhui Medical University, No. 218 Jixi Road, Shushan District, , Anhui, Hefei, 230022, China. 13395690563@qq.com.
Yi-jun
YJ
Zhao
Department of Surgery, The First Affiliated Hospital of Anhui Medical University, No. 218 Jixi Road, Shushan District, , Anhui, Hefei, 230022, China. ruisongwang@163.com.
Guo-bin
GB
Wang
Department of Surgery, The Second Affiliated Hospital of Anhui Medical University, No. 678 Furong Road, Shushan District, , Anhui, Hefei, 230022, China. xp_geng@163.net.
Xiao-ping
XP
Geng
D002681:China; D002985:Clinical Protocols; D017558:Elective Surgical Procedures; D004867:Equipment Design; D006498:Hepatectomy / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods*; D006801:Humans; D057194:Intention to Treat Analysis; D019106:Postoperative Hemorrhage / Q000517:prevention & control*; D011446:Prospective Studies; D012107:Research Design; D018401:Sample Size; D016037:Single-Blind Method; D013523:Surgical Equipment; D013997:Time Factors; D016896:Treatment Outcome