Portal HypertensionPhase 4NCT02925975
Early Precise Diagnosis and Intervention of CPT Based on a Noninvasive 3D-vHPS
A Phase 4 study testing Carvedilol, 3D-vHPS and Routine endoscopic procedures in people with Portal Hypertension and Cirrhosis, run by Changqing Yang at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Portal Hypertension, Cirrhosis
- What is being tested?
- Carvedilol, 3D-vHPS and Routine endoscopic procedures
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Jun 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Proven cirrhosis based on histology or unequivocal clinical, sonographic and laboratory findings
- Child-Pugh score < 9
- No visible gastro-esophageal varies by endoscopy
Who cannot join
- 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
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- Patients with coronary artery diseases, or treated with anticoagulants
- Pregnancy
- Inability to adhere the follow-up
- Any life-threatening disease
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai, 200065
About this study
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)
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.
Read the 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
- Being tested
- Carvedilol, 3D-vHPS, Routine endoscopic procedures
- Medical subject headings
- Hypertension, Portal, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarvedilolDrug
Also called Coreg
Carvedilol starts from 6.25mg daily and increase to 12.5mg once daily in next week if being tolerated.
3D-vHPSDevice
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 proceduresProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Other | 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. Receives: Device: 3D-vHPS |
| Treatment group guided by vPVPG | Experimental | 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. Receives: Drug: Carvedilol; Device: 3D-vHPS; Procedure: Routine endoscopic procedures |
| Follow-up group guided by vPVPG | Experimental | 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. Receives: Drug: Carvedilol; Device: 3D-vHPS |
| Follow-up group guided by endoscopy | Active comparator | 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. Receives: Drug: Carvedilol; Device: 3D-vHPS; Procedure: Routine endoscopic procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of portal hypertensive complications: ascites and variceal bleeding
Measured: 3 years
10% decrease of virtual hepatic venous pressure gradient (HVPG) from baseline level
Measured: 3 years
Secondary outcomes (1)
Mortality rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startJan 2015
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changqing Yang
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Changzheng Hospital, Shanghai 10th People's Hospital
- Responsible party
- Sponsor-investigator, Changqing Yang, Shanghai Tongji Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925975
- Sponsor's protocol ID
- Yang-20161003
- Status last verified
- Feb 2020
- First submitted
- 4 Oct 2016
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02925975
- Acronym / sponsor ID
- Yang-20161003
- Conditions
- Portal Hypertension, Cirrhosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Changqing YangUniversity, hospital or other
- Collaborators
- Shanghai Changzheng Hospital, Shanghai 10th People's Hospital
- Study start
- Jan 2015 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | Other | Device: 3D-vHPSHealthy 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 | Experimental | Drug: Carvedilol, Device: 3D-vHPS, Procedure: Routine endoscopic proceduresEnrolled 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 | Experimental | Drug: Carvedilol, Device: 3D-vHPSCirrhotic 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 comparator | Drug: Carvedilol, Device: 3D-vHPS, Procedure: Routine endoscopic proceduresCirrhotic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Proven cirrhosis based on histology or unequivocal clinical, sonographic and laboratory findings
- Child-Pugh score < 9
- No visible gastro-esophageal varies by endoscopy
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarvedilolAlso: CoregCarvedilol starts from 6.25mg daily and increase to 12.5mg once daily in next week if being tolerated. | Drug | Follow-up group guided by endoscopy, Follow-up group guided by vPVPG, Treatment group guided by vPVPG |
| 3D-vHPSThis 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. | Device | Follow-up group guided by endoscopy, Follow-up group guided by vPVPG, Healthy controls, Treatment group guided by vPVPG |
| Routine endoscopic proceduresThese 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. | Procedure or surgery | Follow-up group guided by endoscopy, Treatment group guided by vPVPG |
Primary outcome
Incidence of portal hypertensive complications: ascites and variceal bleeding
Time frame: 3 years
10% decrease of virtual hepatic venous pressure gradient (HVPG) from baseline level
Time frame: 3 years
1 secondary outcome
Mortality rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carvedilol, 3D-vHPS and Routine endoscopic procedures in people with Portal Hypertension and Cirrhosis, run by Changqing Yang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of portal hypertensive complications: ascites and variceal bleeding (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020; AzTrials last refreshed its copy on 6 Nov 2026.