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

March 26, 2021 updated by: Nanfang Hospital of Southern Medical University

The Effect of Monitoring Portal Venous Pressure on Clinical Outcomes in Patients With Portal Hypertension: a Prospective, Single-center, Observational Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with portal hypertension

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Death or final follow-up time (3 years)
Time Frame: three years
three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2021

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

March 18, 2021

First Submitted That Met QC Criteria

March 26, 2021

First Posted (Actual)

March 29, 2021

Study Record Updates

Last Update Posted (Actual)

March 29, 2021

Last Update Submitted That Met QC Criteria

March 26, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2021-062

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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