跳至主要内容
临床试验/NCT02041065
NCT02041065已完成2 期

Waterjet Versus Ultrasound Dissection During Hepatic Transection

Karolinska University Hospital2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2011年2月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
84
试验地点
2
主要终点
Peroperative bloodloss

研究概览

简要总结

Before liver transection patients are allocated to either waterjet or CUSA to divide the liver parenchyma.

详细描述

Transection time, bloodloss, total operation time and postoperative complication rates are registered.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hepatic tumour suitable for resection
  • patients 18 year or older Segmental resection Local resection Left sided hemihepatectomy

排除标准

  • Right sided hemihepatectoyReresection In Situ Split Liver Extended left- and rightsided hemihepatectomy Lobus caudatus resection Central resections Hilus tumour/Klatskin/Cholangiocarcinoma Surgery on biliary tree Extended resection on other organs
  • Resection on gallbladder Resection on other organs during the same operation.

研究组 & 干预措施

CUSA induced dissection

Active Comparator

CUSA transection of the liver. Ultrasound based destruction of the liver parenchyma to allow separate ligation of the bile duct and intrahepatic vessels.

干预措施: CUSA induced dissection (Device)

Waterjet induced dissection

Experimental

Waterjet induced dissection of the liver during resection.Waterjet dissection device mechanically separates hepatic tissue from bile ducts and vessels, the latter two to be separately ligated.

干预措施: Waterjet induced dissection (Device)

结局指标

主要结局

Peroperative bloodloss

时间窗: During liver transection (on an average<90 min)

Peroperative bloodloss in ml during liver transection by use of either waterjet or CUSA.

次要结局

  • Transection time in minutes(During liver transection (on an average< 90 minutes))
  • Operation time in minutes(Time spent in theater in minutes (on an average <240 minutes))
  • Hospital stay in days(Days spent in hospital after surgery (on an average < 10 days))

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lars Lundell

Professor

Karolinska University Hospital

研究点 (2)

Loading locations...

相似试验