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

Changqing Yang

Status and phase: Unknown; Phase 4

Conditions: Portal Hypertension; Cirrhosis

Treatments: Procedure: Routine endoscopic procedures; Device: 3D-vHPS; Drug: Carvedilol

Study type: Interventional

Funder types: Other

Identifiers

NCT02925975

Yang-20161003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 4 patient groups

Healthy controls

Other group

Description:

Healthy volunteers are enrolled as controls to get a normal range of pressure gradient in different sites of hepatic portal system (HPS), such as portal vein, superior mesenteric vein, inferior mesenteric vein and splenic vein. All enrolled healthy subjects should undergo anatomic computed tomographic angiography (CTA) and Doppler ultrasound for only one time, to rebuild a 3D-vHPS by computer.

Treatment:

Device: 3D-vHPS

Treatment group guided by vPVPG

Experimental group

Description:

Enrolled cirrhotic patients with virtual portal vein pressure gradient (vPVPG) above 12mmHg are only treated by oral carvedilol. Once there are visible varies under the endoscopy, participants will be treated with routine endoscopic procedures.

Treatment:

Device: 3D-vHPS

Procedure: Routine endoscopic procedures

Drug: Carvedilol

Follow-up group guided by vPVPG

Experimental group

Description:

Cirrhotic patients with vPVPG lower than 12mmHg are followed-up with anatomic CTA and Doppler ultrasound every six months. Once vPVPG is higher 12mmHg or visible varies under the endoscopy, participants will be rescheduled to treatment group guided by vPVPG.

Treatment:

Device: 3D-vHPS

Drug: Carvedilol

Follow-up group guided by endoscopy

Active Comparator group

Description:

Cirrhotic patients are followed-up by routine endoscopy. Once there are visible varies, participants will be treated according to Baveno V consensus in portal hypertension, such as oral carvedilol and routine endoscopic procedures.

Treatment:

Device: 3D-vHPS

Procedure: Routine endoscopic procedures

Drug: Carvedilol