Evaluating non-invasive methods for diagnosing portal hypertension
Noninvasive Tools for the Diagnosis of Porto-sinusoidal Vascular Disease: a Single-center, Prospective, Cohort Study
Nanfang Hospital, Southern Medical University · NCT06500403
This study is testing if measuring the stiffness of the liver and spleen can help diagnose portal hypertension in patients who have had chemotherapy, instead of using more invasive methods like liver biopsies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06500403 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of measuring liver and spleen stiffness as non-invasive diagnostic tools for Porto-Sinusoidal Vascular Diseases (PSVD) in patients who have undergone platinum-based chemotherapy. The study will involve a single-center, prospective approach to gather data on the correlation between stiffness measurements and the diagnosis of PSVD, traditionally reliant on invasive liver biopsies. Additionally, the research seeks to identify potential biomarkers that could enhance the diagnostic process for PSVD.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-80 who have received platinum-based chemotherapy for organ tumors.
Not a fit: Patients with liver cirrhosis, those who have undergone liver transplantation, or individuals with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive and more accurate method for diagnosing PSVD, improving patient care.
How similar studies have performed: Previous studies have indicated that liver and spleen stiffness measurements can accurately diagnose and predict outcomes for similar conditions, suggesting a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Nanfang hospital, Southern Medical Uiversity — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Principal investigator: Xiaofeng Zhang — Nanfang Hospital, Southern Medical University
- Study coordinator: Xiaofeng Zhang
- Email: 1282614092@qq.com
- Phone: +8618565552050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non-Cirrhotic Portal Hypertension, Porto-Sinusoidal Vascular Diseases