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

January 4, 2019 updated by: Xiaolong Qi, Nanfang Hospital of Southern Medical University

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vePPG Numerical Correlation
Time Frame: 1 day
Correlation of vePPG numerical value with early PPG numerical value
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immediate PPG Numerical Correlation
Time Frame: 7 days
Correlation of immediate PPG numerical value with early PPG numerical value
7 days
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)
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 24, 2017

Primary Completion (ANTICIPATED)

January 1, 2019

Study Completion (ANTICIPATED)

January 1, 2019

Study Registration Dates

First Submitted

June 4, 2017

First Submitted That Met QC Criteria

June 4, 2017

First Posted (ACTUAL)

June 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 8, 2019

Last Update Submitted That Met QC Criteria

January 4, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHESS1702

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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