Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06500403

Non-invasive Tools for PSVD Diagnosis

Patients treated with platinum-based chemotherapy drugs have the probability of developing PSVD. The diagnosis of PSVD depends on liver biopsy. In addition, the level of portal vein pressure has guiding value in the diagnosis and prognosis of PSVD. Many studies have shown that liver and spleen stiffness have high accuracy in diagnosis and prognosis. The purpose of this study is to evaluate the efficacy of the combination of liver and spleen stiffness in the diagnosis of PSVD and to search for effective biomarkers for the diagnosis of PSVD through a single-center, prospective, observational study.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanfang hospital, Southern Medical Uiversity

Guangzhou, Guangdong, 510080, China

Location status: Recruiting

Location contact

Xiaofeng Zhang

CONTACT

[email protected]

+8618565552050

About this study

PSVD is a supplement to non-cirrhotic portal hypertension and is defined as a class of diseases with characteristic pathological changes based on portal vein or hepatic sinuses abnormalities without cirrhosis. Some patients treated with platinum-based chemotherapy drugs will develop PSVD, which is clinically manifested as portal hypertension related complications. The diagnosis of PSVD depends on liver biopsy. In addition, the level of portal vein pressure has guiding value in the diagnosis and prognosis of PSVD. However, liver biopsy and pressure measurement are invasive methods. Many studies have shown that liver and spleen stiffness have high accuracy in diagnosis and prognosis. The purpose of this study is to evaluate the efficacy of the combination of liver and spleen stiffness in the diagnosis of PSVD and to search for effective biomarkers for the diagnosis of PSVD through a single-center, prospective, observational study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Received platinum chemotherapy for organ tumors;
  • Ages 18-80;
  • sign the informed consent voluntarily.

Exclusion criteria

  • Liver pathology suggested cirrhosis;
  • Underwent liver transplantation;
  • Combined with hepatocellular carcinoma exceeding Milan criteria;
  • Complicated with severe heart, kidney, or lung failure;
  • Pregnant or lactating women;
  • Data is seriously missing;
  • Patients were judged not suitable for participation in this study by the researchers.

Treatment and study plan

liver and stiffness measurement

Diagnostic Test

liver and spleen stiffness measurement are non-invasive tools for evaluation of cirrhosis and portal hypertension

Primary outcomes

  1. Searching for valid non-invasive tools for the diagnosis of PSVD

    Time frame: 2 years

    The sensitivity and specificity of the non-invasive models for the diagnosis of PSVD reached 85% and 60%, respectively

Secondary outcomes

  1. Patients developed portal-hypertension-related complications

    Time frame: 3 years

    clinically significant ascites, esophagogastric variceal hemorrhage, hepatic encephalopathy, etc.

  2. Patients died

    Time frame: 3 years

    All-cause death

  3. Patients underwent liver transplantation

    Time frame: 3 years

    Patients underwent liver transplantation during follow up

  4. Patients reached the final follow-up time

    Time frame: 3 years

    Patients had accepted 3-year follow up

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaofeng Zhang

CONTACT

[email protected]

+8618565552050

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

Noninvasive Tools for the Diagnosis of Porto-sinusoidal Vascular Disease: a Single-center, Prospective, Cohort Study

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Jul 15, 2024
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.