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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02925975
• Other study ID #: Yang-20161003
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: January 2015
• Est. completion date: June 2020

Study information

• Verified date: February 2020
• Source: Shanghai Tongji Hospital, Tongji University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Hypertension
• Hypertension, Portal
• Portal Hypertension

Intervention

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

Device:
• 3D-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.

Procedure:
• Routine 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.

Locations

Country	Name	City	State
China	Shanghai Tongji Hospital, Tongji University School of Medicine	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Changqing Yang	Shanghai 10th People's Hospital, Shanghai Changzheng Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life	The short form Health Survey (SF36-V2)	3 years
Primary	Incidence of portal hypertensive complications: ascites and variceal bleeding		3 years
Primary	10% decrease of virtual hepatic venous pressure gradient (HVPG) from baseline level		3 years
Secondary	Mortality rate		3 years