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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Invasive PPG obtained by means of catheterization.
302 Hospital of PLA
Beijing, Beijing Municipality, China
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
PLA Army General Hospital
Beijing, Beijing Municipality, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Xingtai People's Hospital
Xingtai, Hebei, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University
Luzhou, Sichuan, China
vePPG Numerical Correlation
Correlation of vePPG numerical value with early PPG numerical value
Time frame: 1 day
Immediate PPG Numerical Correlation
Correlation of immediate PPG numerical value with early PPG numerical value
Time frame: 7 days
Diagnostic Performance of vePPG
Accuracy, sensitivity, specificity, positive predictive value and negative predictive value of vePPG to determine re-intervention or not when compared to invasive early PPG as reference (PPG≥12mmHg)
Time frame: 1 day
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