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

• Status: Active, not recruiting
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Changqing Yang
• Collaborators: Shanghai 10th People's Hospital; Shanghai Changzheng Hospital; Shanghai East Hospital,Tongji University School of Medicine; Shanghai Tenth People's Hospital,Tongji University School of Medicine; Xinhua Hospital, Shanghai Jiaotong University School of Medicine
• Treatments: Carvedilol

Criteria

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