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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PPG-detecting software | Diagnostic 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. |
| 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 |
| 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 |
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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:
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Patients with confirmed cirrhosis by imaging tests (upper abdominal ultrasound/CT /MRI) or liver biopsy pathology
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Tongji Hospital, Tongji University School of Medicine | Shanghai | 200065 | China |
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| ID | Term |
|---|---|
| D006975 | Hypertension, Portal |
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| LSM and PLT count | Diagnostic Test | Patients whose LSM >15kPa, or PLT count < 150*10^9 should be screened with upper GI endoscopy |
|
| 2 years |