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

Primary Purpose

Portal Hypertension, Cirrhosis

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Carvedilol
3D-vHPS
Routine endoscopic procedures
Sponsored by
Changqing Yang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Portal Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Shanghai Tongji Hospital, Tongji University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Experimental

Experimental

Active Comparator

Arm Label

Healthy controls

Treatment group guided by vPVPG

Follow-up group guided by vPVPG

Follow-up group guided by endoscopy

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mortality rate

Full Information

First Posted
October 4, 2016
Last Updated
February 24, 2020
Sponsor
Changqing Yang
Collaborators
Shanghai Changzheng Hospital, Shanghai 10th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02925975
Brief Title
Early Precise Diagnosis and Intervention of CPT Based on a Noninvasive 3D-vHPS
Official Title
Early Precise Diagnosis and Intervention of Cirrhotic Portal Hypertension (CPT) Based on a Noninvasive 3D-virtual-model of Hepatic Portal System (3D-vHPS)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Changqing Yang
Collaborators
Shanghai Changzheng Hospital, Shanghai 10th People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Portal Hypertension, Cirrhosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy controls
Arm Type
Other
Arm Description
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.
Arm Title
Treatment group guided by vPVPG
Arm Type
Experimental
Arm Description
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.
Arm Title
Follow-up group guided by vPVPG
Arm Type
Experimental
Arm Description
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.
Arm Title
Follow-up group guided by endoscopy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Carvedilol
Other Intervention Name(s)
Coreg
Intervention Description
Carvedilol starts from 6.25mg daily and increase to 12.5mg once daily in next week if being tolerated.
Intervention Type
Device
Intervention Name(s)
3D-vHPS
Intervention Description
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
Procedure
Intervention Name(s)
Routine endoscopic procedures
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of portal hypertensive complications: ascites and variceal bleeding
Time Frame
3 years
Title
10% decrease of virtual hepatic venous pressure gradient (HVPG) from baseline level
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Mortality rate
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
Quality of life
Description
The short form Health Survey (SF36-V2)
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Shanghai Tongji Hospital, Tongji University School of Medicine
City
Shanghai
ZIP/Postal Code
200065
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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