NCT03470389

Brief Summary

This study is a prospective, non-controlled, multicentre trial in patients with cirrhosis or portal hypertension. In this study, the investigators aim to establish the HVPG using biofluid mechanics (HVPGBFM) model using biofluid mechanics methods and validate the HVPGBFM model. A total of 200 patients will be recruited in this study and each patient will undergo computed tomography, blood tests, Doppler ultrasound and HVPG measurement. The study consists of two independent and consecutive cohorts: original cohort (100 patients) and validation cohort (100 patients). The researchers will establish and improve the HVPGBFM model in the original cohort and assess the model in the validation cohort.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 25, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

March 20, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

December 14, 2018

Status Verified

December 1, 2018

Enrollment Period

2.5 years

First QC Date

February 25, 2018

Last Update Submit

December 12, 2018

Conditions

Liver CirrhosisHypertension, Portal

Keywords

Liver CirrhosisHypertension, PortalHepatic Venous Pressure Gradient (HVPG)Biofluid MechanicsNoninvasive

Outcome Measures

Primary Outcomes (2)

  • Correlation between HVPGBFM and HVPG by Bland-Altman plot.

    The numeric correlation between HVPGBFM and HVPG will be analysed by using Bland and Altman's limits of agreement analysis.

    7 days

  • Correlation between HVPGBFM and HVPG by linear regression analysis.

    The numeric relationship between HVPGBFM and HVPG will be analysed by using linear regression analysis.

    7 days

Study Arms (1)

HVPG

EXPERIMENTAL

Each patient's computed tomography, blood tests, Doppler ultrasound and HVPG measurement will be performed within 30 days and treatments that may affect HVPG value will be avoided during this period.

Procedure: HVPG measurement

Interventions

HVPG measurementPROCEDURE

Each patient's computed tomography, blood tests, Doppler ultrasound and HVPG measurement will be performed within 30 days and treatments that may affect HVPG value will be avoided during this period.

Also known as: Blood test, Doppler ultrasound, Computed tomography
HVPG

Eligibility Criteria

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

You may qualify if:

  • Be at least 18 years of age.
  • Patients with cirrhosis or portal hypertension, scheduled for HVPG measurement.

You may not qualify if:

  • Female patients who are pregnant or nursing.
  • Patients who are medically unstable, terminally or seriously ill, or patients whose clinical course is unpredictable.
  • Patients with clinically unstable cardiac disease, for example: congenital heart defect, arrhythmia, uncontrolled heart failure (NYHA Class IV).
  • Patients with respiratory distress syndrome or clinically unstable pulmonary disease, for example: pulmonary hypertension, pulmonary emboli, pulmonary vasculitis, emphysema.
  • Patients with severe coagulation disorders.
  • Patients with unstable occlusive disease or thrombosis within the hepatic, portal, or mesenteric veins.
  • Patients who are allergic to iodinated contrast.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 200011, China

RECRUITING

Related Publications (1)

  • Lin JY, Zhang CH, Zheng L, Li HJ, Zhu YM, Fan X, Li F, Xia Y, Huang MZ, Yang SH, Qi XL, Huo HZ, Chen HS, Lou XL, Luo M. Establishment and assessment of the hepatic venous pressure gradient using biofluid mechanics (HVPGBFM): protocol for a prospective, randomised, non-controlled, multicentre study. BMJ Open. 2019 Dec 3;9(12):e028518. doi: 10.1136/bmjopen-2018-028518.

    PMID: 31796472DERIVED

MeSH Terms

Conditions

Liver CirrhosisHypertension, Portal

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Meng Luo

    Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    STUDY CHAIR

Central Study Contacts

Jiayun Lin

CONTACT

+86 18017370556lin_jiayun@outlook.com

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
Investigator

Study Record Dates

First Submitted

February 25, 2018

First Posted

March 19, 2018

Study Start

March 20, 2018

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

December 14, 2018

Record last verified: 2018-12

Locations

CN(1)