Early Precise Diagnosis and Intervention of CPT Based on a Noninvasive 3D-vHPS

Early Precise Diagnosis and Intervention of Cirrhotic Portal Hypertension (CPT) Based on a Noninvasive 3D-virtual-model of Hepatic Portal System (3D-vHPS)

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02925975

Enrollment

100

Registered

2016-10-06

Start date

2015-01-31

Completion date

2020-06-30

Last updated

2020-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Portal Hypertension

Brief summary

The aim of this study is to investigate the possibilities of early and precise management to decrease portal vein pressure in cirrhotic patients, guided by a non-invasive 3D-virtual-model of hepatic portal system (3D-vHPS). Healthy volunteers are enrolled to determine the normal range of pressure density in different sites of HPS. Cirrhotic patients without visible gastro-esophageal varies by endoscopy are randomly enrolled to virtual portal vein pressure gradient (vPVPG) monitored or non-vPVPG monitored groups. Non-vPVPG groups are followed-up and treated according to Baveno V consensus in portal hypertension. Patients in vPVPG-monitored groups are followed-up by anatomic computed tomographic angiography (CTA) and Doppler ultrasound every six months. Once vPVPG is above 12mm of mercury (Hg), participants will receive carvedilol treatment. All cirrhotic patients are followed-up with the incidence of portal hypertension-related complications, mortality rate and life quality assessment.

Detailed description

The non-invasive 3D-HPS is a newly-developed test to determine vPVPG based on anatomic computed tomographic angiography (CTA) and Doppler ultrasound. In this study, vPVPG is determined by the 3D-HPS.

Interventions

DRUGCarvedilol

Carvedilol starts from 6.25mg daily and increase to 12.5mg once daily in next week if being tolerated.

DEVICE3D-vHPS

This 3D model of HPS is rebuilt by a software combining the anatomic information of vessels from CTA (computed tomographic angiography) and the blood stream speed of targeted vessel from Doppler Ultrasound.

PROCEDURERoutine endoscopic procedures

These include esophageal band ligation and tissue glue injection in the fundus of stomach by upper GI endoscopy if there are visible varies in cirrhotic patients. There routine procedures are done to prevent potential varies associated bleeding.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Proven cirrhosis based on histology or unequivocal clinical, sonographic and laboratory findings * Child-Pugh score \< 9 * No visible gastro-esophageal varies by endoscopy

Exclusion criteria

* Patients with malignant diseases * Treatment with vasoactive drugs * Prior transjugular intrahepatic portosystemic stent-shunt surgery * Patients with known allergy to iodinated contrast * Treatment with immunosuppressants * Renal sufficiency * Patients with coronary artery diseases, or treated with anticoagulants * Pregnancy * Inability to adhere the follow-up * Any life-threatening disease

Design outcomes

Primary

Measure	Time frame
Incidence of portal hypertensive complications: ascites and variceal bleeding	3 years
10% decrease of virtual hepatic venous pressure gradient (HVPG) from baseline level	3 years

Secondary

Measure	Time frame
Mortality rate	3 years

Other

Measure	Time frame	Description
Quality of life	3 years	The short form Health Survey (SF36-V2)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026