Non-invasive Tools for PSVD Diagnosis

Recruiting

• Conditions: Non-Cirrhotic Portal Hypertension; Porto-Sinusoidal Vascular Diseases
• Interventions: Diagnostic Test: liver and stiffness measurement

• Registration Number: NCT06500403
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Study Timeline

• Study Start: 2024-02-28
• Status Verified: 2024-07
• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-08
• Last Update Submitted: 2024-07-08
• Study First Posted: 2024-07-15
• Last Update Posted: 2024-07-15
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who have received platinum-based chemotherapy for organ tumors	liver and stiffness measurement	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Patients died	3 years	All-cause death
Patients underwent liver transplantation	3 years	Patients underwent liver transplantation during follow up
Patients developed portal-hypertension-related complications	3 years	clinically significant ascites, esophagogastric variceal hemorrhage, hepatic encephalopathy, etc.
Patients reached the final follow-up time	3 years	Patients had accepted 3-year follow up

Trial Locations

Locations (1)

Nanfang hospital, Southern Medical Uiversity; 🇨🇳 Guangzhou, Guangdong, China