Comparative Study on Liver Resection Between Harmonic Scalpel Versus Crush-clamping Method: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Blood loss
研究概览
简要总结
Blood loss during liver resection significantly associates with short term operative outcome. The median blood loss during partial liver resection is 700-1200ml in high-volume centers. Conventional method (crush-clamp) has been a standard technique for liver transection. Technique advances related to liver transection have contributed to reduction in blood loss. Several studies have showed that Harmonic Scalpel in liver resection is safe and easy to use. A nonrandomized study showed use of the Harmonic Scalpel was associated with decreased operative time, blood loss and transfusion requirement, and an increased incidence of postoperative bile leakage. However, no randomized study has compared the difference between liver resection using traditional technology and harmonic Scalpel. The objective of this prospective randomized study is to compare the safety and efficacy of liver resection using the harmonic scalpel device with the "crush-clamp" technique in respect to blood loss, liver transection time, hepatic hilum clamping time, hospital stay and postoperative complications.
详细描述
Blood loss during liver resection significantly associates with short term operative outcome. The median blood loss during partial liver resection is 700-1200ml in high-volume centers. Conventional method (crush-clamp) has been a standard technique for liver transection. Technique advances related to liver transection have contributed to reduction in blood loss. Several studies have showed that Harmonic Scalpel in liver resection is safe and easy to use. A nonrandomized study showed use of the Harmonic Scalpel was associated with decreased operative time, blood loss and transfusion requirement, and an increased incidence of postoperative bile leakage. However, no randomized study has compared the difference between liver resection using traditional technology and harmonic Scalpel. The objective of this prospective randomized study is to compare the safety and efficacy of liver resection using the harmonic scalpel device with the "crush-clamp" technique in respect to blood loss, liver transection time, hepatic hilum clamping time, hospital stay and postoperative complications. All patients submitted to liver resection are randomized into two groups: those submitted to liver resection with the use of "crush-clamp" technique. (group Α) and those with the use of the Harmonic Scalpel device (group Β).
Crush-clamping Method (group A) :Patients submitted to liver resection with the use of "crush-clamping" technique.
Device: Liver parenchymal is crushed by surgeon's fingers or basic surgical clamps to isolate small vessels and biliary radicals, and then divided by suture ligation, electrocautery, or vascular clips.
Harmonic Scalpel (group B) :Patients submitted to liver resection with the use of the Harmonic Scalpel device.Device: liver parenchymal transection is transected by harmonic scalpel, and small vessels and biliary radicals (<3mm) is also divided by harmonic scalpel. Vessels and biliary radicals (≥ 3mm) were divided by suture ligation, electrocautery, or vascular clips.
Primary Outcome Measures:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18y, and ≤80y;
- •No history of liver resection and radiotherapy
- •Liver function: Child A with a normal prothrombin time (<13 seconds) and INR (1.15);
- •Extent of resection ≥2 segment or diameter of tumor (single nodule) ≥ 8cm or cumulative diameter of tumor (multiple nodule) ≥ 8cm; Eligible patients will be stratified by resection in left lobe or right lobe.
- •No tumor thrombosis in main trunk or right and left branch of portal vein or major hepatic vein.
排除标准
- •Recurrent liver tumor; or simultaneous resection of other organs except gallbladder
- •Prothrombin time > 13S;
- •Blood platelets count (BPC) < 60x109
- •Moderate and severe of esophageal varices detected by CT or MRI
- •Diameter of portal vein > 14mm (color ultrasound)
结局指标
主要结局
Blood loss
时间窗: intraoperatively operation（an average of 3 hours)
Amount of blood loss will be assayed during operation.
次要结局
- Hepatic hilar clamping time(duration of clamping of hepatic hilar (an average of 30 minutes))
- Transection time(from Mark of the cutting edge to finish disposed of the cutting edge (an average of 1 hour))
- Postoperative complications(within 7 days after operation)
- Hospital stay(dates from admission to discharge (an average of 8 days))
研究者
Hui-Chuan Sun
Professor
Fudan University