BiClamp Forceps Liver Transection Versus Clamp Crushing Technique in Liver Resections: A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- The Total Blood Loss
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Clamp-Crushing technique
liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted
干预措施: Clamp-Crushing technique (Procedure)
BiClamp forceps hepatectomy
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.
干预措施: BiClamp forceps (Device)
结局指标
主要结局
The Total Blood Loss
时间窗: 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
次要结局
- Liver Transection Time(an expected average of 40 minutes)
- Mortality(90 days)
- Morbidity(90 days)
- Biliary Leakage(90 days)
- Duration of Postoperative Hospital Stay(an expected average of 12 days)
- Number of Participants Requiring a Blood Transfusion(2 days)
- Total Bilirubin(3 postoperative day)
研究者
xpgeng
vice-president
The Second Hospital of Anhui Medical University