Noninvasive Tools for the Diagnosis of Porto-sinusoidal Vascular Disease: a Single-center, Prospective, Cohort Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non-Cirrhotic Portal Hypertension
- Sponsor
- Nanfang Hospital, Southern Medical University
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- Searching for valid non-invasive tools for the diagnosis of PSVD
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
- Patients died(3 years)
- Patients underwent liver transplantation(3 years)
- Patients developed portal-hypertension-related complications(3 years)
- Patients reached the final follow-up time(3 years)