Early Precise Diagnosis and Intervention of Cirrhotic Portal Hypertension (CPT) Based on a Noninvasive 3D-virtual-model of Hepatic Portal System (3D-vHPS)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of portal hypertensive complications: ascites and variceal bleeding
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Proven cirrhosis based on histology or unequivocal clinical, sonographic and laboratory findings
- •Child-Pugh score < 9
- •No visible gastro-esophageal varies by endoscopy
排除标准
- •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
研究组 & 干预措施
Treatment group guided by vPVPG
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.
干预措施: 3D-vHPS (Device)
Healthy controls
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.
干预措施: 3D-vHPS (Device)
Treatment group guided by vPVPG
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.
干预措施: Carvedilol (Drug)
Treatment group guided by vPVPG
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.
干预措施: Routine endoscopic procedures (Procedure)
Follow-up group guided by vPVPG
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.
干预措施: Carvedilol (Drug)
Follow-up group guided by vPVPG
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.
干预措施: 3D-vHPS (Device)
Follow-up group guided by endoscopy
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.
干预措施: Carvedilol (Drug)
Follow-up group guided by endoscopy
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.
干预措施: 3D-vHPS (Device)
Follow-up group guided by endoscopy
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.
干预措施: Routine endoscopic procedures (Procedure)
结局指标
主要结局
Incidence of portal hypertensive complications: ascites and variceal bleeding
时间窗: 3 years
10% decrease of virtual hepatic venous pressure gradient (HVPG) from baseline level
时间窗: 3 years
次要结局
- Mortality rate(3 years)
研究者
Changqing Yang
Chief physician in Digestive department, Professor in Hepatology
Shanghai Tongji Hospital, Tongji University School of Medicine