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

This study is currently recruiting participants.
Verified October 2017 by Xiaolong Qi, Nanfang Hospital of Southern Medical University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03177499
First Posted: June 6, 2017
Last Update Posted: October 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Beijing Shijitan Hospital
302 Hospital of PLA
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
Information provided by (Responsible Party):
Xiaolong Qi, Nanfang Hospital of Southern Medical University
  Purpose
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 Intervention
Hypertension, Portal Procedure: Invasive PPG

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Xiaolong Qi, Nanfang Hospital of Southern Medical University:

Primary Outcome Measures:
  • vePPG Numerical Correlation [ Time Frame: 1 day ]
    Correlation of vePPG numerical value with early PPG numerical value


Secondary Outcome Measures:
  • Immediate PPG Numerical Correlation [ Time Frame: 7 days ]
    Correlation of immediate PPG numerical value with early PPG numerical value

  • Diagnostic Performance of vePPG [ Time Frame: 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)


Estimated Enrollment: 80
Actual Study Start Date: August 24, 2017
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177499


Contacts
Contact: Xiaolong Qi, MD 86-20-61641681 qixiaolong@vip.163.com

Locations
China, Beijing
302 Hospital of PLA Recruiting
Beijing, Beijing, China
Contact: Zhiwei Li, MD         
Principal Investigator: Zhiwei Li, MD         
Beijing Ditan Hospital, Capital Medical University Not yet recruiting
Beijing, Beijing, China
Contact: Jun Cheng, MD         
Principal Investigator: Jun Cheng, MD         
Beijing Shijitan Hospital, Capital Medical University Recruiting
Beijing, Beijing, China
Contact: Fuquan Liu, MD         
Principal Investigator: Fuquan Liu, MD         
PLA Army General Hospital Not yet recruiting
Beijing, Beijing, China
Contact: Juqiang Han, MD         
Principal Investigator: Juqiang Han, MD         
China, Guangdong
Nanfang Hospital, Southern Medical University Not yet recruiting
Guangzhou, Guangdong, China
Contact: Jianbo Zhao, MD         
Principal Investigator: Jianbo Zhao, MD         
The First Affiliated Hospital of Sun Yat-sen University Not yet recruiting
Guangzhou, Guangdong, China
Contact: Xiaoshun He, MD         
Principal Investigator: Xiaoshun He, MD         
The Third Affiliated Hospital of Sun Yat-Sen University Not yet recruiting
Guangzhou, Guangdong, China
Contact: Bo Liu, MD         
Principal Investigator: Bo Liu, MD         
China, Hebei
Xingtai People's Hospital Not yet recruiting
Xingtai, Hebei, China
Contact: Dengxiang Liu, MD         
Principal Investigator: Dengxiang Liu, MD         
China, Hunan
The Third Xiangya Hospital of Central South University Not yet recruiting
Changsha, Hunan, China
Contact: Hongwu Luo, MD         
Principal Investigator: Hongwu Luo, MD         
China, Sichuan
Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University Not yet recruiting
Luzhou, Sichuan, China
Contact: Guangyan Si, MD         
Principal Investigator: Guangyan Si, MD         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Beijing Shijitan Hospital
302 Hospital of PLA
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 302 Hospital of PLA
Study Chair: Xiaolong Qi, MD Nanfang Hospital of Southern Medical University
  More Information

Publications:

Responsible Party: Xiaolong Qi, M.D., Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03177499     History of Changes
Other Study ID Numbers: CHESS1702
First Submitted: June 4, 2017
First Posted: June 6, 2017
Last Update Posted: October 5, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
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, Nanfang Hospital of Southern Medical University:
Portal pressure gradient
Transjugular intrahepatic portosystemic shunt
Virtual imaging-based portal pressure gradient

Additional relevant MeSH terms:
Hypertension
Hypertension, Portal
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases