NCT03177499

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

10 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

August 24, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

January 8, 2019

Status Verified

January 1, 2019

Enrollment Period

1.4 years

First QC Date

June 4, 2017

Last Update Submit

January 4, 2019

Conditions

Hypertension, Portal

Keywords

Portal pressure gradientTransjugular intrahepatic portosystemic shuntVirtual imaging-based portal pressure gradient

Outcome Measures

Primary Outcomes (1)

  • vePPG Numerical Correlation

    Correlation of vePPG numerical value with early PPG numerical value

    1 day

Secondary Outcomes (2)

  • Immediate PPG Numerical Correlation

    7 days

  • Diagnostic Performance of vePPG

    1 day

Study Arms (1)

Single arm study

EXPERIMENTAL

Patients will receive CT angiography, Doppler ultrasound, invasive PPG, and vePPG per protocol. Intervention: Procedure: Invasive PPG

Procedure: Invasive PPG

Interventions

Invasive PPGPROCEDURE

Invasive PPG obtained by means of catheterization.

Single arm study

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

302 Hospital of PLA

Beijing, Beijing Municipality, China

Location

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Beijing Shijitan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

PLA Army General Hospital

Beijing, Beijing Municipality, China

Location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Location

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Location

Xingtai People's Hospital

Xingtai, Hebei, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University

Luzhou, Sichuan, China

Location

Related Publications (5)

  • 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.

    PMID: 27786365BACKGROUND

  • 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.

    PMID: 26047908BACKGROUND

  • 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.

    PMID: 28130066BACKGROUND

  • 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.

    PMID: 22922562BACKGROUND

  • 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.

    PMID: 25398771BACKGROUND

MeSH Terms

Conditions

Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Fuquan Liu, MD

    Beijing Shijitan Hospital, Capital Medical University

    PRINCIPAL INVESTIGATOR

  • Zhiwei Li, MD

    Beijing 302 Hospital

    PRINCIPAL INVESTIGATOR

  • Xiaolong Qi, MD

    Nanfang Hospital, Southern Medical University

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

June 4, 2017

First Posted

June 6, 2017

Study Start

August 24, 2017

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

January 8, 2019

Record last verified: 2019-01

Locations

CN(10)