Value of Transient Elastography in Predicting Postoperative Liver Failure in Patients Undergoing Liver Resection for Hepatocellular Carcinoma.
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Cut-off value of liver stiffness measured in kilopascal (kPa) able to predict the occurrence of postoperative liver failure.
研究概览
简要总结
The purpose of this study is to determine whether liver transient elastography performed before the surgical procedure is able to predict liver failure in patients undergoing hepatectomy for hepatocellular carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients already scheduled to undergo liver resection fo hepatocellular carcinoma
排除标准
- 未提供
结局指标
主要结局
Cut-off value of liver stiffness measured in kilopascal (kPa) able to predict the occurrence of postoperative liver failure.
时间窗: Participants will be followed for the duration of postoperative hospital stay, an expected average of 4 weeks
Definition of the cut-off value in kPa able to predict postoperative liver failure, i.e. the presence of at least one of the following variables: ascites causing a delay in the removal of surgical drainages and/or requiring paracentesis; increase of bilirubin levels \>3 mg/dL; alteration of coagulation factors requiring plasma infusion with an INR above 1.50 (with serum bilirubin levels \<12mg/dL); renal impairment, defined as blood urea nitrogen \>2.00 g/L and/or increase of serum creatinine \>2.00 mg/dL requiring only loop diuretics, dopamine/terlipressin, or dialysis.
次要结局
未报告次要终点
研究者
Matteo Cescon
MD, PhD, Assistant Professor of Surgery
IRCCS Azienda Ospedaliero-Universitaria di Bologna