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

NCT ID: NCT03177499

Last Updated: 2019-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-24

Study Completion Date

2019-01-31

Brief Summary

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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.

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Detailed Description

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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 (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.

Conditions

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Hypertension, Portal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single arm study

Patients will receive CT angiography, Doppler ultrasound, invasive PPG, and vePPG per protocol.

Intervention: Procedure: Invasive PPG

Group Type EXPERIMENTAL

Invasive PPG

Intervention Type PROCEDURE

Invasive PPG obtained by means of catheterization.

Interventions

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Invasive PPG

Invasive PPG obtained by means of catheterization.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Shijitan Hospital, Capital Medical University

OTHER

Sponsor Role collaborator

Beijing 302 Hospital

OTHER

Sponsor Role collaborator

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Xingtai People's Hospital

OTHER

Sponsor Role collaborator

Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Beijing Ditan Hospital

OTHER

Sponsor Role collaborator

PLA Army General Hospital

UNKNOWN

Sponsor Role collaborator

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Xiaolong Qi

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fuquan Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Shijitan Hospital, Capital Medical University

Zhiwei Li, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing 302 Hospital

Xiaolong Qi, MD

Role: STUDY_CHAIR

Nanfang Hospital, Southern Medical University

Locations

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302 Hospital of PLA

Beijing, Beijing Municipality, China

Site Status

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Beijing Shijitan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

PLA Army General Hospital

Beijing, Beijing Municipality, China

Site Status

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Site Status

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status

Xingtai People's Hospital

Xingtai, Hebei, China

Site Status

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status

Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University

Luzhou, Sichuan, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 27786365 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26047908 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28130066 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22922562 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25398771 (View on PubMed)

Other Identifiers

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CHESS1702

Identifier Type: -

Identifier Source: org_study_id

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