Non-invasive Tools for PSVD Diagnosis

Noninvasive Tools for the Diagnosis of Porto-sinusoidal Vascular Disease: a Single-center, Prospective, Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Non-Cirrhotic Portal Hypertension; Porto-Sinusoidal Vascular Diseases
• Intervention / Treatment: Diagnostic test: liver and stiffness measurement

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Xiaofeng Zhang; Phone Number: +8618565552050; Email: 1282614092@qq.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Nanfang hospital, Southern Medical Uiversity
      • Contact: Xiaofeng Zhang; Phone Number: +8618565552050; Email: 1282614092@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients who have received platinum-based chemotherapy for organ tumors	Diagnostic test: liver and stiffness measurement; liver and spleen stiffness measurement are non-invasive tools for evaluation of cirrhosis and portal hypertension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University
• Investigators: Principal Investigator: Xiaofeng Zhang, Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): July 15, 2024
• Last Update Submitted That Met QC Criteria: July 8, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Liver Diseases; Vascular Diseases; Hypertension, Portal
• Other Study ID Numbers: NFEC-2023-566

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No