NCT04786782

The vPPG-detecting Software Guided Management of Cirrhotic Portal Hypertension

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Changqing Yang · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Portal Hypertension
• Cirrhosis, Liver

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	PPG-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_TEST	LSM and PLT count	Patients whose LSM \>15kPa, or PLT count \< 150\*10\^9 should be screened with upper GI endoscopy

Timeline

• Start date: 2021-03-03
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2021-03-08
• Last updated: 2023-04-20

Locations

1 site across 1 country: China