The vPPG-detecting Software Guided Management of Cirrhotic Portal Hypertension

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Management of Patients With Cirrhotic Portal Hypertension Based on the Noninvasive Portal Pressure Gradient (vPPG) Detecting Software, a Prospective and Controlled Cohort Study

Conditions
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Portal Hypertension, Cirrhosis, Liver

Intervention / Treatment
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* Diagnostic Test: PPG-detecting software
* Diagnostic Test: LSM and PLT count


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Three-dimensional reconstruction group<br>Portal hypertension is controlled with upper endoscopic screening and vPPG was detected by the noninvasive PPG-detecting software | Diagnostic Test: PPG-detecting software<br>* 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.<br>|
| Natural follow-up group<br>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 | Diagnostic Test: LSM and PLT count<br>* Patients whose LSM >15kPa, or PLT count < 150*10^9 should be screened with upper GI endoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The morbidity of cirrhotic decompensated events | The occurence rate of cirrhotic decompensated events of enrolled patients | 2 years | 
| The mortality of cirrhosis | Patients who die because of cirrhosis | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spared endoscopies | Patients who don't need upper endoscopic monitoring | 2 years | 
| Number of missed VNT | Missed cases of patients who have varices needing treatment | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual portal pressure gradient, Enhanced upper abdominal CT, Portal ultrasound, Portal hypertension, Cirrhosis