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

NCT ID: NCT02925975

Last Updated: 2020-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2020-06-30

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.

Conditions

Portal Hypertension; Cirrhosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: OTHER

3D-vHPS

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

Carvedilol

Intervention Type: DRUG

Carvedilol starts from 6.25mg daily and increase to 12.5mg once daily in next week if being tolerated.

3D-vHPS

Intervention Type: DEVICE

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.

Routine endoscopic procedures

Intervention Type: PROCEDURE

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.

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.

Group Type: EXPERIMENTAL

Carvedilol

Intervention Type: DRUG

Carvedilol starts from 6.25mg daily and increase to 12.5mg once daily in next week if being tolerated.

3D-vHPS

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Carvedilol

Intervention Type: DRUG

Carvedilol starts from 6.25mg daily and increase to 12.5mg once daily in next week if being tolerated.

3D-vHPS

Intervention Type: DEVICE

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.

Routine endoscopic procedures

Intervention Type: PROCEDURE

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.

Interventions

Carvedilol

Carvedilol starts from 6.25mg daily and increase to 12.5mg once daily in next week if being tolerated.

Intervention Type: DRUG

3D-vHPS

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.

Intervention Type: DEVICE

Routine endoscopic procedures

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.

Intervention Type: PROCEDURE

Other Intervention Names

Coreg

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Changzheng Hospital

OTHER

Sponsor Role: collaborator

Shanghai 10th People's Hospital

OTHER

Sponsor Role: collaborator

Changqing Yang

OTHER

Sponsor Role: lead

Responsible Party

Changqing Yang

Chief physician in Digestive department, Professor in Hepatology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Shanghai Tongji Hospital, Tongji University School of Medicine

Shanghai, , China

Countries

China

Other Identifiers

Yang-20161003

Identifier Type: -

Identifier Source: org_study_id