Clinical trial NCT06500403: Non-invasive Tools for PSVD Diagnosis
Official title: Noninvasive Tools for the Diagnosis of Porto-sinusoidal Vascular Disease: a Single-center, Prospective, Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-Cirrhotic Portal Hypertension
Porto-Sinusoidal Vascular Diseases
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients had organ tumors and had received platinum chemotherapy before, the expected survival time is not less than half of year.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Searching for valid non-invasive tools for the diagnosis of PSVD
timeFrame: 2 years
Secondary outcomes:
measure: Patients developed portal-hypertension-related complications
timeFrame: 3 years
measure: Patients died
timeFrame: 3 years
measure: Patients underwent liver transplantation
timeFrame: 3 years
measure: Patients reached the final follow-up time
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang hospital, Southern Medical Uiversity
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Xiaofeng Zhang
role: PRINCIPAL_INVESTIGATOR
References: