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

Phase 4

• Conditions: Cirrhosis; Portal Hypertension
• Interventions: Device: 3D-vHPS; Drug: Carvedilol; Procedure: Routine endoscopic procedures

• Registration Number: NCT02925975
• Lead Sponsor: Changqing Yang

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-10-04
• Study First Submitted QC: 2016-10-05
• Study First Posted: 2016-10-06
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-25
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy controls	3D-vHPS	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 group guided by vPVPG	3D-vHPS	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.
Follow-up group guided by endoscopy	Carvedilol	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.
Follow-up group guided by vPVPG	3D-vHPS	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.
Follow-up group guided by endoscopy	3D-vHPS	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 group guided by vPVPG	Routine endoscopic procedures	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.
Follow-up group guided by endoscopy	Routine endoscopic procedures	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 group guided by vPVPG	Carvedilol	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.
Follow-up group guided by vPVPG	Carvedilol	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Mortality rate	3 years

Trial Locations

Locations (1)

Shanghai Tongji Hospital, Tongji University School of Medicine; 🇨🇳 Shanghai, China