Non-invasive Tools for PSVD Diagnosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: liver and stiffness measurement.
- Who it may be relevant to
- Registry conditions: Non-Cirrhotic Portal Hypertension, Porto-Sinusoidal Vascular Diseases. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Noninvasive Tools for the Diagnosis of Porto-sinusoidal Vascular Disease: a Single-center, Prospective, Cohort Study
Overview
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.
Interventions
- Diagnostic test liver and stiffness measurement
liver and spleen stiffness measurement are non-invasive tools for evaluation of cirrhosis and portal hypertension
Primary outcome measures
- Searching for valid non-invasive tools for the diagnosis of PSVD [Time frame: 2 years]
Secondary outcome measures (4)
- Patients developed portal-hypertension-related complications [Time frame: 3 years]
- Patients died [Time frame: 3 years]
- Patients underwent liver transplantation [Time frame: 3 years]
- Patients reached the final follow-up time [Time frame: 3 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Nanfang hospital, Southern Medical Uiversity — Guangzhou
Identifiers
NCT: NCT06500403 · NFEC-2023-566