Health TrialsbyHealthPanel

Non-invasive Tools for PSVD Diagnosis

ConditionsNon-Cirrhotic Portal HypertensionPorto-Sinusoidal Vascular Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorNanfang Hospital, Southern Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Received platinum chemotherapy for organ tumors;

Ages 18-80;

sign the informed consent voluntarily.

Disqualifiers

Liver pathology suggested cirrhosis;

Underwent liver transplantation;

Combined with hepatocellular carcinoma exceeding Milan criteria;

Complicated with severe heart, kidney, or lung failure;

Trial population

Patients had organ tumors and had received platinum chemotherapy before, the expected survival time is not less than half of year.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • liver and stiffness measurement

    Diagnostic test

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

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Patients who have received platinum-based chemotherapy for organ tumors1 intervention

Trial outcomes

Primary outcomes

1

Searching for valid non-invasive tools for the diagnosis of PSVD

The sensitivity and specificity of the non-invasive models for the diagnosis of PSVD reached 85% and 60%, respectively

Time frame
2 years

Secondary outcomes

1

Patients developed portal-hypertension-related complications

clinically significant ascites, esophagogastric variceal hemorrhage, hepatic encephalopathy, etc.

Time frame
3 years
2

Patients died

All-cause death

Time frame
3 years
3

Patients underwent liver transplantation

Patients underwent liver transplantation during follow up

Time frame
3 years
4

Patients reached the final follow-up time

Patients had accepted 3-year follow up

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanfang Hospital, Southern Medical University

Lead sponsor

Source ClinicalTrials.gov
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