Usefulness of BiClamp Forceps for Liver Resection: A Randomized Clinical Trial

BiClamp Forceps Liver Transection Versus Clamp Crushing Technique in Liver Resections: A Randomized Clinical Trial

The purpose of this study is to compare short-term and long-term efficacy of BiClamp forceps hepatectomy and clamp-crushing technique for parenchymal transection during elective hepatic resection.

Background: Blood loss and the need for blood transfusions during the liver transection have shown to be correlated with higher morbidity and mortality rates and with worsen prognosis. Various devices of liver parenchymal transection have been developed with a view to reducing the intraoperative blood loss. However, to the present there is no randomized controlled trial evaluating the technique of BiClamp forceps during the liver transection. The goal of the present study was to evaluate the safety and effectiveness of BiClamp forceps transection in comparison to the clamp crushing technique in patients offered liver resection. Intervention: One hundred patients with hepatobiliary disease need undergo hepatectomy at Anhui medical university were selected and divided into BiClamp forceps hepatectomy group and clamp-crushing hepatectomy group, each group contains 50 cases. Results: Clinical data include: blood loss during liver transection, total blood loss, blood transfusion, hospital stay, morbidity, mortality, biliary leakage, postoperative liver function, liver transection time, operation time, resection margins, need for portal trial clamping. Statistical method: groups t-test, univariate/multivariate analysis, logistic regression analysis, mixed linear regression and Cox survival analysis were used.

BiClamp forceps hepatectomy, Clamp crushing technique, Liver parenchyma transection, Randomized controlled trial

liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted

The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.

Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps

Blood loss during operation. Blood loss was calculated from the beginning to the end of operation The amount of blood loss was measured from the suction volume after subtraction of rinse fluids and from the weight of soaked gauzes that were used during transection

Biliary leakage was documented in line with the International Study Group of Liver Surgery (ISGLS) definitions and grading systems

Administration of blood transfusions is documented for the intraoperative and postoperative period until 48 hours postoperatively

Inclusion Criteria: Both male and female, aged 18 or older Patients scheduled to undergo hepatic resection for some benign or malignant hepatobiliary disease Child-Pugh class A or B liver function BiClamp forceps hepatectomy and clamp-crushing feasible based on preoperative imaging No tumor invasion the main vein, hepatic artery and vein and major inferior vena cava No extrahepatic metastasis Voluntary participation in the study, and informed consent. Exclusion Criteria: Age <18 years or> 65 years , pregnant or lactating women Preoperative liver function evaluation: Child-Pugh C grade Laparoscopic hepatectomy Extrahepatic metastasis Tumor invasion the main vein, hepatic artery and vein and major inferior vena cava The patient refused to sign the informed consent form

Kooby DA, Stockman J, Ben-Porat L, Gonen M, Jarnagin WR, Dematteo RP, Tuorto S, Wuest D, Blumgart LH, Fong Y. Influence of transfusions on perioperative and long-term outcome in patients following hepatic resection for colorectal metastases. Ann Surg. 2003 Jun;237(6):860-9; discussion 869-70. doi: 10.1097/01.SLA.0000072371.95588.DA.

Gurusamy KS, Pamecha V, Sharma D, Davidson BR. Techniques for liver parenchymal transection in liver resection. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD006880. doi: 10.1002/14651858.CD006880.pub2.

Itoh S, Fukuzawa K, Shitomi Y, Okamoto M, Kinoshita T, Taketomi A, Shirabe K, Wakasugi K, Maehara Y. Impact of the VIO system in hepatic resection for patients with hepatocellular carcinoma. Surg Today. 2012 Dec;42(12):1176-82. doi: 10.1007/s00595-012-0306-6. Epub 2012 Sep 20.

Chen JM, Geng W, Liu FB, Zhao HC, Xie SX, Hou H, Zhao YJ, Wang GB, Geng XP. BiClamp(R) forcep liver transection versus clamp crushing technique for liver resection: study protocol for a randomized controlled trial. Trials. 2015 Apr 30;16:201. doi: 10.1186/s13063-015-0722-1.