- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04786782
The vPPG-detecting Software Guided Management of Cirrhotic Portal Hypertension
April 18, 2023 updated by: Changqing Yang
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
250
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
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Shanghai, China, 200065
- Shanghai Tongji Hospital, Tongji University School of Medicine
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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 to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with confirmed cirrhosis by imaging tests (upper abdominal ultrasound/CT /MRI) or liver biopsy pathology
Description
Inclusion Criteria:
Inpatients (Shanghai Tongji Hospital) with cirrhosis, which is confirmed by the imaging tests (upper abdominal ultrasound/CT/MRI) or liver biopsy pathology.
Exclusion Criteria:
- 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
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Three-dimensional reconstruction group
Portal hypertension is controlled with upper endoscopic screening and vPPG was detected by the noninvasive PPG-detecting software
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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.
|
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
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Patients whose LSM >15kPa, or PLT count < 150*10^9 should be screened with upper GI endoscopy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The morbidity of cirrhotic decompensated events
Time Frame: 2 years
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The occurence rate of cirrhotic decompensated events of enrolled patients
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2 years
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The mortality of cirrhosis
Time Frame: 2 years
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Patients who die because of cirrhosis
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spared endoscopies
Time Frame: 2 years
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Patients who don't need upper endoscopic monitoring
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2 years
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Number of missed VNT
Time Frame: 2 years
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Missed cases of patients who have varices needing treatment
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 3, 2021
Primary Completion (Anticipated)
September 30, 2023
Study Completion (Anticipated)
September 30, 2023
Study Registration Dates
First Submitted
March 2, 2021
First Submitted That Met QC Criteria
March 4, 2021
First Posted (Actual)
March 8, 2021
Study Record Updates
Last Update Posted (Actual)
April 20, 2023
Last Update Submitted That Met QC Criteria
April 18, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Yang-20210205
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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