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

NCT04820166 | Unknown

• 1 other identifier: NFEC-2021-062
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Gastroesophageal varices bleeding

  Patients with gastroesophageal varices has hematemesis or melena, and active bleeding or red sign can be seen under endoscopy

  three years

• Ascites

  Peritoneal effusion was seen under ultrasound

  three years

• Hepatic encephalopathy

  Patients with altered consciousness or unresponsiveness, accompanied by elevated blood ammonia

  three years

Secondary Outcomes (1)

• Death or final follow-up time (3 years)

  three years

Interventions

monitoring portal pressure gradient or hepatic venous pressure gradient OTHER

measuring portal pressure gradient or hepatic venous pressure gradient regularly

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with portal hypertension

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital

Guangzhou, Guangdong, China

RECRUITING

Related Publications (2)

• Liu M, Zhang X, Cheng X, He Q, Zhou T, Wang H, Li B, Luo W, Li J, Li H, Lin Z, Song J, Wang W, Huang J, Ji Y, Zhou D, Xie W, Yang Q, Tu M, Luo X, Zhang X, Yan H, Chen J. Indocyanine Green Clearance Test via Pulse Dye Densitometry for Portal Hypertension Diagnosis in cACLD. Liver Int. 2025 Dec;45(12):e70425. doi: 10.1111/liv.70425.

  PMID: 41178521 DERIVED

• 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.

  PMID: 40105356 DERIVED

MeSH Terms

Conditions

Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Central Study Contacts

Xiaofeng Zhang

CONTACT

+8618565552050; 1282614092@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 29, 2021
• Study Start: March 12, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 29, 2021

Record last verified: 2021-03

Locations

CN (1)