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

February 24, 2020 updated by: Changqing Yang

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200065
        • Shanghai Tongji Hospital, Tongji University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Device: 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.
Experimental: 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.
Device: 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.
Drug: Carvedilol
Carvedilol starts from 6.25mg daily and increase to 12.5mg once daily in next week if being tolerated.
Other Names:
  • Coreg
Procedure: 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.
Experimental: 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.
Device: 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.
Drug: Carvedilol
Carvedilol starts from 6.25mg daily and increase to 12.5mg once daily in next week if being tolerated.
Other Names:
  • Coreg
Active Comparator: 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.
Device: 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.
Drug: Carvedilol
Carvedilol starts from 6.25mg daily and increase to 12.5mg once daily in next week if being tolerated.
Other Names:
  • Coreg
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of portal hypertensive complications: ascites and variceal bleeding
Time Frame: 3 years
3 years
10% decrease of virtual hepatic venous pressure gradient (HVPG) from baseline level
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality rate
Time Frame: 3 years
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 3 years
The short form Health Survey (SF36-V2)
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changqing Yang

Collaborators

Shanghai 10th People's Hospital
Shanghai Changzheng Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

October 4, 2016

First Submitted That Met QC Criteria

October 5, 2016

First Posted (Estimate)

October 6, 2016

Study Record Updates

Last Update Posted (Actual)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 24, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Yang-20161003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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