NCT04786782

Brief Summary

The aim of this study is to investigate the possibilities and effectiveness of managing cirrhotic portal hypertension using the non-invasive portal pressure gradient (PPG) detecting software. In this study, the three-dimensional reconstruction and natural follow-up methods have been respectively applied in the experimental (1st) and active comparator (2nd) group. The virtual PPG is calculated with anatomical and hemodynamic information of portal system collected by ultrasound and CT tests. Cirrhosis patients in the 1st group, with calculated vPPG values, are managed with upper GI endoscopic results. Besides, patients in the 2nd group, are managed according to the most updated Chinese clinical guideline for cirrhotic portal hypertension, namely, patients with either liver stiffness measurement (LSM) \>15kPa or PLT count \<150\*10\^9 should be screened and treated with upper GI endoscopy. The morbidity of decompensated cirrhotic events and mortality of patients in two arms will be compared. The cutoff values of vPPG to spare endoscopies with low missed VNT (varices needing treatment) are preliminarily determined with the cohort data.

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
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

March 3, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 8, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

April 20, 2023

Status Verified

April 1, 2023

Enrollment Period

2.6 years

First QC Date

March 2, 2021

Last Update Submit

April 18, 2023

Conditions

Portal HypertensionCirrhosis, Liver

Keywords

Virtual portal pressure gradientEnhanced upper abdominal CTPortal ultrasoundPortal hypertensionCirrhosis

Outcome Measures

Primary Outcomes (2)

  • The morbidity of cirrhotic decompensated events

    The occurence rate of cirrhotic decompensated events of enrolled patients

    2 years

  • The mortality of cirrhosis

    Patients who die because of cirrhosis

    2 years

Secondary Outcomes (2)

  • Spared endoscopies

    2 years

  • Number of missed VNT

    2 years

Study Arms (2)

Three-dimensional reconstruction group

Portal hypertension is controlled with upper endoscopic screening and vPPG was detected by the noninvasive PPG-detecting software

Diagnostic Test: PPG-detecting software

Natural follow-up group

Portal hypertension is controlled with the most updated guideline for clinical practice, namely, cirrhotic patients with either liver stiffness measurement \>15kPa or PLT\<150\*10\^9 should be screened with upper GI endoscopy and treated according to endoscopic results

Diagnostic Test: LSM and PLT count

Interventions

PPG-detecting softwareDIAGNOSTIC_TEST

Virtual PPG (vPPG) of patients in experimental group is calculated based on anatomical and hemodynamic information of portal system collected by ultrasound and CT tests.

Three-dimensional reconstruction group
LSM and PLT countDIAGNOSTIC_TEST

Patients whose LSM \>15kPa, or PLT count \< 150\*10\^9 should be screened with upper GI endoscopy

Natural follow-up group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with confirmed cirrhosis by imaging tests (upper abdominal ultrasound/CT /MRI) or liver biopsy pathology

You may qualify if:

  • Inpatients (Shanghai Tongji Hospital) with cirrhosis, which is confirmed by the imaging tests (upper abdominal ultrasound/CT/MRI) or liver biopsy pathology.

You may not qualify if:

  • \. Portal vein embolism;
  • \. Splenectomy;
  • \. Hepatic encephalopathy;
  • \. Hepatic space occupying lesions (such as hepatic cysts, hemangiomas, etc.) with diameter \> 3cm and local compression effect;
  • \. Contraindications of enhanced CT test, such as iodine allergy, peripheral veins are too thin to inject contrast medium;
  • \. Contraindications of upper GI endoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Tongji Hospital, Tongji University School of Medicine

Shanghai, 200065, China

Location

MeSH Terms

Conditions

Hypertension, PortalLiver CirrhosisFibrosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator,Head of Gastroenterology and Hepatology, Chief Physician, Professor

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 8, 2021

Study Start

March 3, 2021

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

April 20, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)