Noninvasive diagnostic model for high-risk varices in liver cirrhosis
Establishment of Noninvasive Diagnosis Model for High-risk Varices in Cirrhosis Patients Based on iLivTouch
This study is testing a new way to screen for dangerous varices in people with liver cirrhosis using a device that measures liver stiffness and other factors to see if it can improve diagnosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Beijing 302 Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06392503 on ClinicalTrials.gov |
What this trial studies
This observational ambispective cohort study aims to validate the Baveno VI guideline and develop a new diagnostic model for screening high-risk varices (HRV) in patients with liver cirrhosis using the iLivTouch device. The study will analyze both retrospective data from hospital records and prospectively collected data from participants who meet the inclusion criteria. By measuring liver stiffness and other laboratory indexes, the study seeks to establish a more applicable cutoff value for diagnosing HRV and potentially identify new indexes to enhance diagnostic efficiency. The study will run for a minimum of 6 months at each center, with possible extensions to meet enrollment targets.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 with a clinical or imaging diagnosis of liver cirrhosis.
Not a fit: Patients who have experienced decompensation events or have certain comorbidities, such as hepatocellular carcinoma or those currently on specific medications, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive and more efficient method for diagnosing high-risk varices in patients with liver cirrhosis.
How similar studies have performed: Other studies have shown success with similar diagnostic approaches, but this specific model using iLivTouch is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-75; 2. Patients with liver cirrhosis diagnosed by clinical or imaging diagnosis; 3. The interval of iLivTouch and esophagogastroduodenoscopy is no more than 3 months; Exclusion Criteria: 1. the interval between esophagogastroduodenoscopy and iLivTouch is more than 3 months; 2. any decompensation events (ascites, hepatic encephalopathy or gastroesophageal variceal bleeding) during endoscopy or iLivTouch examination, or during the interval between them; 3. currently taking nonselective beta blocker/ antiplatelet / anticoagulant drugs; 4. hepatocellular carcinoma; 5. after transjugular intrahepatic portosystemic shunt surgery; 6. after liver transplantation. 7. portal-spleen-mesenteric venous thrombosis; 8. patients with splenectomy; 9. BMI ≥ 30; 10. patients with acute active hepatitis or patients with cholestatic hepatitis; 11. IQR/median of liver stiffness measurement \> 30%.
Where this trial is running
Beijing, Beijing
- the Fifth Medical Center, Chinese PLA General Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Fu junliang — the Fifth Medical Center, Chinese PLA General Hospital
- Study coordinator: Fu junliang, PHD
- Email: fjunliang@163.com
- Phone: 010-66933214
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.