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

• Sponsor: Nanfang Hospital of Southern Medical University (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03177499
• Collaborator: Beijing Shijitan Hospital, Capital Medical University (Other), Beijing 302 Hospital (Other), The Third Xiangya Hospital of Central South University (Other), Xingtai People's Hospital (Other), Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University (Other), First Affiliated Hospital, Sun Yat-Sen University (Other), Beijing Ditan Hospital (Other), PLA Army General Hospital (Other), Third Affiliated Hospital, Sun Yat-Sen University (Other)
• Enrollment: 0
• Locations: 10
• Arm: 1
• Anticipated Duration (Months): 16.3
• Patients Per Site: 0
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension, Portal	Procedure: Invasive PPG	N/A

Detailed 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

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Virtual Imaging-based Early Portal Pressure Gradient (vePPG) After Placement of Transjugular Intrahepatic Portosystemic Shunts in Patients With Portal Hypertension
• Actual Study Start Date: Aug 24, 2017
• Anticipated Primary Completion Date: Jan 1, 2019
• Anticipated Study Completion Date: Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single arm study Patients will receive CT angiography, Doppler ultrasound, invasive PPG, and vePPG per protocol. Intervention: Procedure: Invasive PPG	Procedure: Invasive PPG; Invasive PPG obtained by means of catheterization.

Outcome Measures

Primary Outcome Measures

1. vePPG Numerical Correlation [1 day]

   Correlation of vePPG numerical value with early PPG numerical value

Secondary Outcome Measures

1. Immediate PPG Numerical Correlation [7 days]

   Correlation of immediate PPG numerical value with early PPG numerical value

2. Diagnostic Performance of vePPG [1 day]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	302 Hospital of PLA	Beijing	Beijing	China
2	Beijing Ditan Hospital, Capital Medical University	Beijing	Beijing	China
3	Beijing Shijitan Hospital, Capital Medical University	Beijing	Beijing	China
4	PLA Army General Hospital	Beijing	Beijing	China
5	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong	China
6	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong	China
7	The Third Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong	China
8	Xingtai People's Hospital	Xingtai	Hebei	China
9	The Third Xiangya Hospital of Central South University	Changsha	Hunan	China
10	Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University	Luzhou	Sichuan	China

Sponsors and Collaborators

• Nanfang Hospital of Southern Medical University
• Beijing Shijitan Hospital, Capital Medical University
• Beijing 302 Hospital
• 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

Investigators

• Principal Investigator: Fuquan Liu, MD, Beijing Shijitan Hospital, Capital Medical University
• Principal Investigator: Zhiwei Li, MD, Beijing 302 Hospital
• Study Chair: Xiaolong Qi, MD, Nanfang Hospital of Southern Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Xiaolong Qi, M.D., Nanfang Hospital of Southern Medical University
• ClinicalTrials.gov Identifier: NCT03177499
• Other Study ID Numbers: CHESS1702
• First Posted: Jun 6, 2017
• Last Update Posted: Jan 8, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xiaolong Qi, M.D., Nanfang Hospital of Southern Medical University: Portal pressure gradient; Transjugular intrahepatic portosystemic shunt; Virtual imaging-based portal pressure gradient
• Additional relevant MeSH terms: Hypertension, Portal; Hypertension

Study Results

No Results Posted as of Jan 8, 2019