The Effect of Monitoring PVP on Clinical Outcomes in Patients With PH

Recruiting

• Conditions: Portal Hypertension

• Registration Number: NCT04820166
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

The complications associated with portal hypertension in cirrhosis are the main cause of death in patients with cirrhosis. The level of portal venous pressure is closely related to the prognosis of patients. HVPG (hepatic venous pressure gradient) is the "gold standard" for predicting portal venous pressure and an important indicator for evaluating the efficacy of NSBBS. However, monitoring HVPG has many limitations，and the clinical application is also limited to a certain extent. Therefore, this study intends to clarify the guiding value of monitoring portal venous pressure in the clinical diagnosis and treatment of portal hypertension patients through a single-center, prospective and observational study. Therefore, this study intends to clarify the guiding value of monitoring portal venous pressure in the clinical diagnosis and treatment of portal hypertension patients through a single-center, prospective and observational study. At the same time, to explore the correlation between HVPG and PPG in cirrhosis patients at different stages and different etiologies, and to evaluate the role of spleen stiffness in predicting the severity of esophageal and gastric varices in patients with portal hypertension, and to find biomarkers to predict the risk of complications related to portal hypertension.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-03
• Study Start: 2021-03-12
• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-26
• Last Update Submitted: 2021-03-26
• Study First Posted: 2021-03-29
• Last Update Posted: 2021-03-29
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• With chronic liver disease
• Age 18-80 years
• Patients who require a portal pressure measurement at the discretion of the treating physician
• Voluntarily signed informed consent

Exclusion Criteria

• With serious cardiopulmonary disease or other diseases affect survival
• With severe renal dysfunction
• Concomitant portal vein cavernous degeneration or extensive portal vein thrombosis
• Women who are planning to become pregnant or who are pregnant or breastfeeding
• The researcher judged that it was not suitable to participate in this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ascites	three years	Peritoneal effusion was seen under ultrasound
Hepatic encephalopathy	three years	Patients with altered consciousness or unresponsiveness, accompanied by elevated blood ammonia
Gastroesophageal varices bleeding	three years	Patients with gastroesophageal varices has hematemesis or melena, and active bleeding or red sign can be seen under endoscopy

Secondary Outcome Measures

Name	Time	Method
Death or final follow-up time (3 years)	three years

Trial Locations

Locations (1)

Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China