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临床试验/NCT02042794
NCT02042794Unknown不适用

Randomised Controlled Trial of Pringle Manoeuvre Versus Portal Vein Clamping in Patients Undergoing Liver Resection for Colorectal Liver Metastasis - A Pilot Study

The Leeds Teaching Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
The ability to recruit and randomise patients into the study

研究概览

简要总结

Liver resection is an operation to remove the diseased part of the liver. The liver is supplied by two vessels, the hepatic artery and the portal vein supplying 25% and 75% respectively of the total blood flow with 50% oxygen from each vessel. During liver resection it is standard practice to clamp both vessels(Pringle's manoeuvre), so as to avoid bleeding. Clamping both the vessels deprives the unaffected liver from nutrients required for survival. Reinstating the blood supply causes further damage by pouring harmful substances into the liver, which accumulate during the clamping. We hypothesize that not clamping the oxygen rich hepatic artery will cause less damage to the liver.

Our aim is to compare the Pringle manoeuvre with portal vein clamping, to identify if the latter will result in less tissue injury and thereby fewer complications. Initially we aim to conduct a pilot study. The main objective is to ensure that patients can be successfully recruited and that data capture is complete. The secondary outcomes will be development of infective complications by 30 days following surgery, bleeding and blood transfusion requirements, heart/chest complications, recovery of liver functions, growth of remnant liver, death within 30 days following surgery, length of high dependency unit/hospital stay and quality of life at 3 months after surgery.

There is published literature on the safety of this method and in the event of any intraoperative problems, the procedure will be converted to the standard Pringle manoeuvre. The Liver Unit at St James's University Hospital has four surgeons performing around 270 liver cancer resections per year, of which nearly 160 are for bowel cancer spread. Considering the team's experience in research and liver surgery, we believe it is well placed to conduct the trial in a safe and efficient manner.

研究设计

研究类型
Observational
时间视角
Prospective

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

  • At least 18 years of age
  • Undergoing liver resection for CRLM
  • Portal venous clamping as considered appropriate
  • Participating patients should be able to understand the study objectives and be able to give written consent
  • Able to complete study questionnaire

排除标准

  • Patients having simultaneous bowel and hepatic surgery
  • Patients participating in other trials that could impact the outcomes measures being recorded
  • Patients who are pregnant
  • Patients taking immunosuppressive medication

结局指标

主要结局

The ability to recruit and randomise patients into the study

时间窗: 14months

次要结局

未报告次要终点

研究者

发起方
The Leeds Teaching Hospitals NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

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