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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Portal Hypertension, Cirrhosis

Intervention / Treatment
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* Drug: Carvedilol
* Device: 3D-vHPS
* Procedure: Routine endoscopic procedures


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy controls<br>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. | Device: 3D-vHPS<br>* 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.<br>|
| Experimental: Treatment group guided by vPVPG<br>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. | Drug: Carvedilol<br>* Carvedilol starts from 6.25mg daily and increase to 12.5mg once daily in next week if being tolerated.<br>* Other names: Coreg;Device: 3D-vHPS<br>* 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.<br>Procedure: Routine endoscopic procedures<br>* 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.<br>|
| Experimental: Follow-up group guided by vPVPG<br>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. | Drug: Carvedilol<br>* Carvedilol starts from 6.25mg daily and increase to 12.5mg once daily in next week if being tolerated.<br>* Other names: Coreg;Device: 3D-vHPS<br>* 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.<br>|
| Active Comparator: Follow-up group guided by endoscopy<br>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. | Drug: Carvedilol<br>* Carvedilol starts from 6.25mg daily and increase to 12.5mg once daily in next week if being tolerated.<br>* Other names: Coreg;Device: 3D-vHPS<br>* 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.<br>Procedure: Routine endoscopic procedures<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate |  | 3 years |