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| Name | Class |
|---|---|
| Beijing Shijitan Hospital, Capital Medical University | OTHER |
| Beijing 302 Hospital | OTHER |
| The Third Xiangya Hospital of Central South University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm study | Experimental | Patients will receive CT angiography, Doppler ultrasound, invasive PPG, and vePPG per protocol. Intervention: Procedure: Invasive PPG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Invasive PPG | Procedure | Invasive PPG obtained by means of catheterization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| vePPG Numerical Correlation | Correlation of vePPG numerical value with early PPG numerical value | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate PPG Numerical Correlation | Correlation of immediate PPG numerical value with early PPG numerical value | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fuquan Liu, MD | Beijing Shijitan Hospital, Capital Medical University | Principal Investigator |
| Zhiwei Li, MD | Beijing 302 Hospital | Principal Investigator |
| Xiaolong Qi, MD | Nanfang Hospital, Southern Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 302 Hospital of PLA | Beijing | Beijing Municipality | China | |||
| Beijing Ditan Hospital, Capital Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27786365 | Background | Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the study of liver diseases. Hepatology. 2017 Jan;65(1):310-335. doi: 10.1002/hep.28906. Epub 2016 Dec 1. No abstract available. | |
| 26047908 |
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| ID | Term |
|---|---|
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| Xingtai People's Hospital |
| OTHER |
| Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University | UNKNOWN |
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Beijing Ditan Hospital | OTHER |
| PLA Army General Hospital | UNKNOWN |
| Third Affiliated Hospital, Sun Yat-Sen University | OTHER |
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| 1 day |
| 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 |
| de Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available. |
| 28130066 | Background | Silva-Junior G, Turon F, Baiges A, Cerda E, Garcia-Criado A, Blasi A, Torres F, Hernandez-Gea V, Bosch J, Garcia-Pagan JC. Timing Affects Measurement of Portal Pressure Gradient After Placement of Transjugular Intrahepatic Portosystemic Shunts in Patients With Portal Hypertension. Gastroenterology. 2017 May;152(6):1358-1365. doi: 10.1053/j.gastro.2017.01.011. Epub 2017 Jan 24. |
| 22922562 | Background | Min JK, Leipsic J, Pencina MJ, Berman DS, Koo BK, van Mieghem C, Erglis A, Lin FY, Dunning AM, Apruzzese P, Budoff MJ, Cole JH, Jaffer FA, Leon MB, Malpeso J, Mancini GB, Park SJ, Schwartz RS, Shaw LJ, Mauri L. Diagnostic accuracy of fractional flow reserve from anatomic CT angiography. JAMA. 2012 Sep 26;308(12):1237-45. doi: 10.1001/2012.jama.11274. |
| 25398771 | Background | Qi X, Li Z, Huang J, Zhu Y, Liu H, Zhou F, Liu C, Xiao C, Dong J, Zhao Y, Xu M, Xing S, Xu W, Yang C. Virtual portal pressure gradient from anatomic CT angiography. Gut. 2015 Jun;64(6):1004-5. doi: 10.1136/gutjnl-2014-308543. Epub 2014 Nov 14. No abstract available. |