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临床试验/NCT03177499
NCT03177499撤回不适用

Virtual Imaging-based Early Portal Pressure Gradient (vePPG) After Placement of Transjugular Intrahepatic Portosystemic Shunts in Patients With Portal Hypertension

Nanfang Hospital, Southern Medical University10 个研究点 分布在 1 个国家开始时间: 2017年8月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
10
主要终点
vePPG Numerical Correlation

研究概览

简要总结

Portal pressure gradient (PPG) above 12 mmHg after transjugular intrahepatic portosystemic shunt (TIPS) increases the risk of portal hypertension complications. Currently, a PPG reduction <12 mmHg after TIPS is the most consistent threshold associated with almost complete protection from variceal bleeding and ascites. However, the measurement of PPG requires an invasive procedure. A recent study investigated the variations in PPG measurements collected at different time points after placement of TIPS and demonstrated that a time point of at least 24 hours after which PPG values were best maintained (early PPG). It is of great clinical value to propose that an immediate PPG measurement fail to accurately identify the risk of decompensated event. And early PPG would change the decision making for re-intervention or not. However, the repeated invasive examination is extremely difficult to follow in clinical practice worldwide. The prospective multicenter trial aims to assess the diagnostic performance of a virtual imaging-based early portal pressure gradient (vePPG) (investigational technology) from CT angiography and Doppler ultrasound with invasive early PPG measurement as reference. The study participants with portal hypertension will be prospectively recruited at 10 high-volume liver centers in China.

详细描述

Portal pressure gradient (PPG) above 12 mmHg after transjugular intrahepatic portosystemic shunt (TIPS) increases the risk of portal hypertension complications. Currently, a PPG reduction <12 mmHg after TIPS is the most consistent threshold associated with almost complete protection from variceal bleeding and ascites. However, the measurement of PPG requires an invasive procedure. A recent study investigated the variations in PPG measurements collected at different time points after placement of TIPS and demonstrated that a time point of at least 24 hours after which PPG values were best maintained (early PPG). It is of great clinical value to propose that an immediate PPG measurement fail to accurately identify the risk of decompensated event. And early PPG would change the decision making for re-intervention or not. However, the repeated invasive examination is extremely difficult to follow in clinical practice worldwide. The prospective multicenter trial aims to assess the diagnostic performance of a virtual imaging-based early portal pressure gradient (vePPG) (investigational technology) from CT angiography and Doppler ultrasound with invasive early PPG measurement as reference. The study participants with portal hypertension will be prospectively recruited at 10 high-volume liver centers (Beijing Shijitan Hospital; 302 Hospital of PLA; Nanfang Hospital, Southern Medical University; The Third Xiangya Hospital of Central South University; Xingtai People's Hospital; Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University; First Affiliated Hospital, Sun Yat-Sen University; Beijing Ditan Hospital; PLA Army General Hospital; Third Affiliated Hospital, Sun Yat-Sen University) in China.

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

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients providing written informed consent
  • Patients with portal hypertension and received the placement of TIPS
  • Patients with invasive immediate PPG and early PPG measurement
  • Has undergone > 64 multi-detector row CT angiography and Doppler ultrasound within 3 days prior to invasive early PPG measurement

排除标准

  • Any severe adverse events after TIPS placement
  • Inability to adhere to study procedures
  • Prior devascularization operation
  • Has received a liver transplant
  • Patients with known anaphylactic allergy to iodinated contrast
  • Pregnancy or unknown pregnancy status
  • Patient requires an emergent procedure
  • Any active, serious, life-threatening disease

研究组 & 干预措施

Single arm study

Experimental

Patients will receive CT angiography, Doppler ultrasound, invasive PPG, and vePPG per protocol.

Intervention: Procedure: Invasive PPG

干预措施: Invasive PPG (Procedure)

结局指标

主要结局

vePPG Numerical Correlation

时间窗: 1 day

Correlation of vePPG numerical value with early PPG numerical value

次要结局

  • Immediate PPG Numerical Correlation(7 days)
  • Diagnostic Performance of vePPG(1 day)

研究者

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

Xiaolong Qi

M.D.

Nanfang Hospital, Southern Medical University

研究点 (10)

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