Non-invasive prediction of esophageal varices in cirrhosis patients
Southern Medical University of Nanfang Hospital
This study is testing a new way to predict if people with cirrhosis have dangerous swollen veins in their esophagus without needing invasive procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 992 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 1 site (Guangzhou) |
| Trial ID | NCT04890730 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to develop a non-invasive method for predicting the presence of gastroesophageal varices in patients with cirrhosis. Participants will undergo a series of laboratory tests, elastography, and serum proteomic differential protein testing, including liver and spleen elastography. The study will validate the Baveno VI criteria by comparing various clinical parameters to assess the diagnostic value of these non-invasive methods. Patients will be followed up every 6 months to 1 year to monitor outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with a clinical or pathological diagnosis of cirrhosis who are scheduled for electronic gastroscopy.
Not a fit: Patients who have undergone liver transplantation, TIPS procedures, or those with neurological or psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable non-invasive screening method for identifying patients at risk of gastroesophageal varices, potentially reducing the need for invasive endoscopic procedures.
How similar studies have performed: While the approach of using non-invasive methods for predicting varices is being explored, this specific methodology is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1. The age ranged from 18 to 80 years. 2. Clinical or pathological diagnosis of cirrhosis; 3. Electronic gastroscopy is planned; 4. To agree and sign the informed consent; Exclusion Criteria: * 1.Orthotopic liver transplantation patients; 2. Patients who have undergone transjugular intrahepatic portosystemic shunt (TIPS),or previous surgical shunt; 3. Pregnant women; 4. Neurological or psychiatric disorders;
Where this trial is running
Guangzhou
- Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University — Guangzhou, China (Recruiting)
Study contacts
- Study coordinator: Jinjun Chen, PHd
- Email: chjj@smu.edu.cn
- Phone: 8618588531001
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.