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Virtual Imaging-based Early Portal Pressure Gradient (vePPG) (CHESS1702) — vePPG  

Hypertension, Portal Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03177499
Study type Interventional
Source Nanfang Hospital of Southern Medical University
Contact
Status Withdrawn
Phase N/A
Start date August 24, 2017
Completion date January 2019
View Details
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