Cirrhosis, Liver, Portal Hypertension
Conditions
Keywords
Virtual portal pressure gradient, Enhanced upper abdominal CT, Portal ultrasound, Portal hypertension, Cirrhosis
Brief 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. 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.
Interventions
DIAGNOSTIC_TESTPPG-detecting software
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.
DIAGNOSTIC_TESTLSM and PLT count
Patients whose LSM \>15kPa, or PLT count \< 150\*10\^9 should be screened with upper GI endoscopy
Sponsors
Changqing Yang
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The morbidity of cirrhotic decompensated events | 2 years | The occurence rate of cirrhotic decompensated events of enrolled patients |
| The mortality of cirrhosis | 2 years | Patients who die because of cirrhosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spared endoscopies | 2 years | Patients who don't need upper endoscopic monitoring |
| Number of missed VNT | 2 years | Missed cases of patients who have varices needing treatment |
Countries
China
Outcome results
None listed