跳至主要内容
临床试验/NCT03753880
NCT03753880Unknown不适用

Efficacy of NHS-PEG (Pentaerythirol Polyethylene Glycol Ether Tetra-succinimidyl Glutarate) Coated Collagen Patch (Hemopatch®) for Prevention of Bile Leaks After Liver Resection

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2019年10月23日最近更新:
适应症

试验速览

阶段
不适用
入组人数
71
试验地点
2
主要终点
Bile leaks

研究概览

简要总结

In liver surgery bile leaks are still a major cause of postoperative morbidity with the need for additional diagnostic tests, additional interventions, prolonged hospital stay, mortality and higher costs. Efforts to further reduce the rate of postoperative biliary morbidity are therefore important.A new polyethylene glycol (PEG)-coated collagen pad (Hemopatch®) showed faster and more sustained hemostasis, less blood loss, and lower hematoma formation than the fibrin-coated collagen patch in an animal model. This might be attributed to an improved tissue adherence of the PEG-coated pad. We hypothesize that this strong adherence to the hepatic resection surface may also serve as a mechanical sealant of bile ducts thus preventing biliary leakage.

To date, there exists no study including a sufficient number of patients to clarify whether sealing of the hepatic resection surface with Hemopatch® can reduce the rate of biliary leaks and data regarding the expected difference in the incidence of biliary complications are lacking.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective hepatic resection

排除标准

  • Minor atypical hepatectomy without a plain cut surface
  • Contraindications to the application of Hemopatch®

结局指标

主要结局

Bile leaks

时间窗: 30 days

biliary leak is defined as bilirubin concentration in the abdominal drain fluid at least 3 times the serum bilirubin concentration on or after postoperative day 3 or as the need for radiologic or operative intervention resulting from biliary collections or biliary peritonitis

次要结局

  • Bleeding(30 days)
  • Mortalitiy(30 days)
  • Abscess(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christoph Schwarz

Principal Investigator

Medical University of Vienna

研究点 (2)

Loading locations...

相似试验

Hemopatch for Prevention of Bile Leaks After Liver... | 临床试验