Portal HypertensionNCT04786782
The vPPG-detecting Software Guided Management of Cirrhotic Portal Hypertension
An observational study of Portal Hypertension and Cirrhosis, Liver, run by Changqing Yang at 1 site in China.
Trial summary
The aim of this study is to investigate the possibilities and effectiveness of managing cirrhotic portal hypertension using the non-invasive portal pressure gradient (PPG) detecting software. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Portal Hypertension, Cirrhosis, Liver
- What is being tested?
- PPG-detecting software and LSM and PLT count
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2021to 30 Sep 2023
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with confirmed cirrhosis by imaging tests (upper abdominal ultrasound/CT /MRI) or liver biopsy pathology
Who may be able to join
- Inpatients (Shanghai Tongji Hospital) with cirrhosis, which is confirmed by the imaging tests (upper abdominal ultrasound/CT/MRI) or liver biopsy pathology.
Who cannot join
- 1. Portal vein embolism;
- 2. Splenectomy;
- 3. Hepatic encephalopathy;
- 4. Hepatic space occupying lesions (such as hepatic cysts, hemangiomas, etc.) with diameter > 3cm and local compression effect;
- 5. Contraindications of enhanced CT test, such as iodine allergy, peripheral veins are too thin to inject contrast medium;
- 6. Contraindications of upper GI endoscopy
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: Clinical Management of Patients With Cirrhotic Portal Hypertension Based on the Noninvasive Portal Pressure Gradient (vPPG) Detecting Software, a Prospective and Controlled Cohort Study
The aim of this study is to investigate the possibilities and effectiveness of managing cirrhotic portal hypertension using the non-invasive portal pressure gradient (PPG) detecting software. In this study, the three-dimensional reconstruction and natural follow-up methods have been respectively applied in the experimental (1st) and active comparator (2nd) group. The virtual PPG is calculated with anatomical and hemodynamic information of portal system collected by ultrasound and CT tests. Cirrhosis patients in the 1st group, with calculated vPPG values, are managed with upper GI endoscopic results. Besides, patients in the 2nd group, are managed according to the most updated Chinese clinical guideline for cirrhotic portal hypertension, namely, patients with either liver stiffness measurement (LSM) >15kPa or PLT count <150*10^9 should be screened and treated with upper GI endoscopy. The morbidity of decompensated cirrhotic events and mortality of patients in two arms will be compared. The cutoff values of vPPG to spare endoscopies with low missed VNT (varices needing treatment) are preliminarily determined with the cohort data.
- Conditions
- Portal Hypertension, Cirrhosis, Liver
- Being tested
- PPG-detecting software, LSM and PLT count
- Keywords
- Virtual portal pressure gradient, Enhanced upper abdominal CT, Portal ultrasound, Portal hypertension, Cirrhosis
- Medical subject headings
- Hypertension, Portal, Liver Cirrhosis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPG-detecting softwareDiagnostic test
Virtual PPG (vPPG) of patients in experimental group is calculated based on anatomical and hemodynamic information of portal system collected by ultrasound and CT tests.
LSM and PLT countDiagnostic test
Patients whose LSM >15kPa, or PLT count < 150*10^9 should be screened with upper GI endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Three-dimensional reconstruction group | Portal hypertension is controlled with upper endoscopic screening and vPPG was detected by the noninvasive PPG-detecting software Receives: Diagnostic Test: PPG-detecting software | |
| Natural follow-up group | Portal hypertension is controlled with the most updated guideline for clinical practice, namely, cirrhotic patients with either liver stiffness measurement >15kPa or PLT<150*10^9 should be screened with upper GI endoscopy and treated according to endoscopic results Receives: Diagnostic Test: LSM and PLT count |
What is being measured
The primary outcome is the main question the study is designed to answer.
The morbidity of cirrhotic decompensated events
The occurence rate of cirrhotic decompensated events of enrolled patients
Measured: 2 years
The mortality of cirrhosis
Patients who die because of cirrhosis
Measured: 2 years
Secondary outcomes (2)
Spared endoscopies
Patients who don't need upper endoscopic monitoring
Measured: 2 years
Number of missed VNT
Missed cases of patients who have varices needing treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start3 Mar 2021
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changqing Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Changqing Yang, Shanghai Tongji Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786782
- Sponsor's protocol ID
- Yang-20210205
- Status last verified
- Apr 2023
- First submitted
- 2 Mar 2021
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Management of Patients With Cirrhotic Portal Hypertension Based on the Noninvasive Portal Pressure Gradient (vPPG) Detecting Software, a Prospective and Controlled Cohort Study
- ClinicalTrials.gov ID
- NCT04786782
- Acronym / sponsor ID
- Yang-20210205
- Conditions
- Portal Hypertension, Cirrhosis, Liver
- Keywords
- Virtual portal pressure gradient, Enhanced upper abdominal CT, Portal ultrasound, Portal hypertension, Cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Changqing YangUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 8 Mar 2021 (actual)
- 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 and effectiveness of managing cirrhotic portal hypertension using the non-invasive portal pressure gradient (PPG) detecting software. In this study, the three-dimensional reconstruction and natural follow-up methods have been respectively applied in the experimental (1st) and active comparator (2nd) group. The virtual PPG is calculated with anatomical and hemodynamic information of portal system collected by ultrasound and CT tests. Cirrhosis patients in the 1st group, with calculated vPPG values, are managed with upper GI endoscopic results. Besides, patients in the 2nd group, are managed according to the most updated Chinese clinical guideline for cirrhotic portal hypertension, namely, patients with either liver stiffness measurement (LSM) >15kPa or PLT count <150*10^9 should be screened and treated with upper GI endoscopy. The morbidity of decompensated cirrhotic events and mortality of patients in two arms will be compared. The cutoff values of vPPG to spare endoscopies with low missed VNT (varices needing treatment) are preliminarily determined with the cohort data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Three-dimensional reconstruction group | – | Diagnostic Test: PPG-detecting softwarePortal hypertension is controlled with upper endoscopic screening and vPPG was detected by the noninvasive PPG-detecting software |
| Natural follow-up group | – | Diagnostic Test: LSM and PLT countPortal hypertension is controlled with the most updated guideline for clinical practice, namely, cirrhotic patients with either liver stiffness measurement >15kPa or PLT<150*10^9 should be screened with upper GI endoscopy and treated according to endoscopic results |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with confirmed cirrhosis by imaging tests (upper abdominal ultrasound/CT /MRI) or liver biopsy pathology
Key inclusion criteria (1 listed)
- Inpatients (Shanghai Tongji Hospital) with cirrhosis, which is confirmed by the imaging tests (upper abdominal ultrasound/CT/MRI) or liver biopsy pathology.
Key exclusion criteria (6 listed)
- 1. Portal vein embolism;
- 2. Splenectomy;
- 3. Hepatic encephalopathy;
- 4. Hepatic space occupying lesions (such as hepatic cysts, hemangiomas, etc.) with diameter > 3cm and local compression effect;
- 5. Contraindications of enhanced CT test, such as iodine allergy, peripheral veins are too thin to inject contrast medium;
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 |
|---|---|---|
| PPG-detecting softwareVirtual PPG (vPPG) of patients in experimental group is calculated based on anatomical and hemodynamic information of portal system collected by ultrasound and CT tests. | Diagnostic test | Three-dimensional reconstruction group |
| LSM and PLT countPatients whose LSM >15kPa, or PLT count < 150*10^9 should be screened with upper GI endoscopy | Diagnostic test | Natural follow-up group |
Primary outcome
The morbidity of cirrhotic decompensated events
Time frame: 2 years
The occurence rate of cirrhotic decompensated events of enrolled patients
The mortality of cirrhosis
Time frame: 2 years
Patients who die because of cirrhosis
2 secondary outcomes
Spared endoscopies
Time frame: 2 years
Number of missed VNT
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Individual participant dataSharing planned: No
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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?
An observational study of Portal Hypertension and Cirrhosis, Liver, 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 1 inclusion and 6 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 20 Apr 2023. 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.
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?
The morbidity of cirrhotic decompensated events (time frame: 2 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 20 Apr 2023.