BiClamp® forcep liver transection versus clamp crushing technique for liver resection: study protocol for a randomized controlled trial

Jiang-ming Chen, Wei Geng, Fu-bao Liu, Hong-chuan Zhao, Sheng-xue Xie, Hui Hou, Yi-jun Zhao, Guo-bin Wang, Xiao-ping Geng, Jiang-ming Chen, Wei Geng, Fu-bao Liu, Hong-chuan Zhao, Sheng-xue Xie, Hui Hou, Yi-jun Zhao, Guo-bin Wang, Xiao-ping Geng

Abstract

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/design: 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.

Discussion: 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.

Trial registration: This trial was registered with Clinicaltrials.gov (identifier: NCT02197481 ) on 15 July 2014.

Figures

Figure 1
Figure 1
Flowchart according to CONSORT (Figure 1).
Figure 2
Figure 2
BiClamp forceps liver transection. A BiClamp forceps; B The surgical process of hepatectomy by BiClamp forceps.

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Source: PubMed

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