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

Phase 3

Completed

Brief Summary: 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.

Detailed Description: 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:

1. 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.

2. Statistical method: groups t-test, univariate/multivariate analysis, logistic regression analysis, mixed linear regression and Cox survival analysis were used.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Clamp-Crushing technique	Clamp-Crushing technique	liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted
BiClamp forceps hepatectomy	BiClamp forceps	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.

Primary Outcome Measures

Name	Time	Method
The Total Blood Loss	an expected average of 80 minutes	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

Secondary Outcome Measures

Name	Time	Method
Liver Transection Time	an expected average of 40 minutes	liver transection time was calculated from the beginning to the end of the liver resection
Mortality	90 days	Operative mortality was defined as any death resulting from a complication during surgery
Morbidity	90 days
Biliary Leakage	90 days	Biliary leakage was documented in line with the International Study Group of Liver Surgery (ISGLS) definitions and grading systems
Duration of Postoperative Hospital Stay	an expected average of 12 days	Time from day of operation to day of discharge
Number of Participants Requiring a Blood Transfusion	2 days	Administration of blood transfusions is documented for the intraoperative and postoperative period until 48 hours postoperatively
Total Bilirubin	3 postoperative day	serum total bilirubin on 3 postoperative day (umol/L)