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

The Second Hospital of Anhui Medical University

Status and phase: Completed; Phase 3

Conditions: Hepatobiliary Disease

Treatments: Device: BiClamp forceps; Procedure: Clamp-Crushing technique

Study type: Interventional

Funder types: Other

Identifiers

NCT02197481

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Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

Clamp-Crushing technique

Active Comparator group

Description:

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

Treatment:

Procedure: Clamp-Crushing technique

BiClamp forceps hepatectomy

Experimental group

Description:

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.

Treatment:

Device: BiClamp forceps