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

Hypertension, Portal Clinical Trial

— vePPG  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03177499
• Other study ID #: CHESS1702
• Status: Withdrawn
• Phase: N/A
• Start date: August 24, 2017
• Est. completion date: January 2019

Study information

• Verified date: January 2019
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Portal

Intervention

Procedure:
• Invasive PPG
Invasive PPG obtained by means of catheterization.

Locations

Country	Name	City	State
China	302 Hospital of PLA	Beijing	Beijing
China	Beijing Ditan Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Shijitan Hospital, Capital Medical University	Beijing	Beijing
China	PLA Army General Hospital	Beijing	Beijing
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
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	Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University	Luzhou	Sichuan
China	Xingtai People's Hospital	Xingtai	Hebei

Sponsors (10)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University, Beijing 302 Hospital, Beijing Ditan Hospital, Beijing Shijitan Hospital, First Affiliated Hospital, Sun Yat-Sen University, PLA Army General Hospital, The Third Xiangya Hospital of Central South University, Third Affiliated Hospital, Sun Yat-Sen University, Xingtai People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. Erratum in: Hepatology. 2017 Jul;66(1):304. — View Citation

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. — View Citation

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. — View Citation

Silva-Junior G, Turon F, Baiges A, Cerda E, García-Criado Á, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vePPG Numerical Correlation	Correlation of vePPG numerical value with early PPG numerical value	1 day
Secondary	Immediate PPG Numerical Correlation	Correlation of immediate PPG numerical value with early PPG numerical value	7 days
Secondary	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)	1 day