Early Precise Diagnosis and Intervention of CPT Based on a Noninvasive 3D-vHPS
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2015
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 4, 2016
CompletedFirst Posted
Study publicly available on registry
October 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedFebruary 25, 2020
February 1, 2020
5.4 years
October 4, 2016
February 24, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Mortality rate
3 years
Other Outcomes (1)
Quality of life
3 years
Study Arms (4)
Healthy controls
OTHERHealthy 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
EXPERIMENTALEnrolled 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
EXPERIMENTALCirrhotic 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
ACTIVE COMPARATORCirrhotic 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.
Interventions
Carvedilol starts from 6.25mg daily and increase to 12.5mg once daily in next week if being tolerated.
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.
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.
Eligibility Criteria
You may qualify if:
- Proven cirrhosis based on histology or unequivocal clinical, sonographic and laboratory findings
- Child-Pugh score \< 9
- No visible gastro-esophageal varies by endoscopy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Changqing Yanglead
- Shanghai Changzheng Hospitalcollaborator
- Shanghai 10th People's Hospitalcollaborator
Study Sites (1)
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai, 200065, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief physician in Digestive department, Professor in Hepatology
Study Record Dates
First Submitted
October 4, 2016
First Posted
October 6, 2016
Study Start
January 1, 2015
Primary Completion
June 1, 2020
Study Completion
June 1, 2020
Last Updated
February 25, 2020
Record last verified: 2020-02