Non-invasive Tools for PSVD Diagnosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-28

Study Completion Date

2029-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non-Cirrhotic Portal Hypertension Porto-Sinusoidal Vascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients who have received platinum-based chemotherapy for organ tumors

liver and stiffness measurement

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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liver and stiffness measurement

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No