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

NCT ID: NCT04820166

Last Updated: 2021-03-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-12
• Study Completion Date: 2025-12-31

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.

Conditions

Portal Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

monitoring portal pressure gradient or hepatic venous pressure gradient

measuring portal pressure gradient or hepatic venous pressure gradient regularly

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nanfang Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaofeng Zhang

Role: CONTACT

1282614092@qq.com

+8618565552050

Facility Contacts

Xiaofeng Zhang

Role: primary

1282614092@qq.com

References

Zhang X, Zhou L, Liang W, Cheng X, He Q, Li H, Luo W, Huang J, Li J, Wang W, Tu M, Wang H, Ou P, Wen B, Xiao L, Zhou D, Wong VW, Chen J. Identification of Clinically Significant Portal Hypertension in cACLD Individuals With Spleen Stiffness Measurement. Liver Int. 2025 Apr;45(4):e16241. doi: 10.1111/liv.16241.

Reference Type: DERIVED

PMID: 40105356 (View on PubMed)

Other Identifiers

NFEC-2021-062

Identifier Type: -

Identifier Source: org_study_id