Non-Cirrhotic Portal Hypertension, Porto-Sinusoidal Vascular Diseases
Conditions
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.
Interventions
DIAGNOSTIC_TESTliver and stiffness measurement
liver and spleen stiffness measurement are non-invasive tools for evaluation of cirrhosis and portal hypertension
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Received platinum chemotherapy for organ tumors; 2. Ages 18-80; 3. sign the informed consent voluntarily.
Exclusion criteria
1. Liver pathology suggested cirrhosis; 2. Underwent liver transplantation; 3. Combined with hepatocellular carcinoma exceeding Milan criteria; 4. Complicated with severe heart, kidney, or lung failure; 5. Pregnant or lactating women; 6. Data is seriously missing; 7. Patients were judged not suitable for participation in this study by the researchers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Searching for valid non-invasive tools for the diagnosis of PSVD | 2 years | The sensitivity and specificity of the non-invasive models for the diagnosis of PSVD reached 85% and 60%, respectively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients developed portal-hypertension-related complications | 3 years | clinically significant ascites, esophagogastric variceal hemorrhage, hepatic encephalopathy, etc. |
| Patients died | 3 years | All-cause death |
| Patients underwent liver transplantation | 3 years | Patients underwent liver transplantation during follow up |
| Patients reached the final follow-up time | 3 years | Patients had accepted 3-year follow up |
Countries
China
Contacts
Primary ContactXiaofeng Zhang
Outcome results
None listed