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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hepatobiliary Disease

Intervention / Treatment
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* Procedure: Clamp-Crushing technique
* Device: BiClamp forceps


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clamp-Crushing technique<br>liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted | Procedure: Clamp-Crushing technique<br>* Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps<br>|
| Experimental: BiClamp forceps hepatectomy<br>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. | Device: BiClamp forceps<br>* liver transection during hepatectomy by BiClamp forceps<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Total Blood Loss | 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 | an expected average of 80 minutes | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BiClamp forceps hepatectomy, Clamp crushing technique, Liver parenchyma transection, Randomized controlled trial