Using EUS elastography to predict complications from liver cirrhosis
A Prospective Study on the Utility of Endoscopic Ultrasound Elastography (EUS-E) for Predicting Cirrhotic-related Complications in Patients With Chronic Liver Diseases
This study is testing if a special ultrasound can help predict serious complications in people with liver cirrhosis by measuring the stiffness of their liver and spleen.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Sha Tin, New Territories) |
| Trial ID | NCT04155398 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of endoscopic ultrasound elastography (EUS-E) in measuring liver and spleen stiffness as indicators of liver cirrhosis and portal hypertension. By assessing tissue stiffness, the study aims to predict the risk of complications such as gastroesophageal variceal bleeding, which is a significant cause of morbidity and mortality in cirrhotic patients. The study includes patients with radiologic features suggestive of cirrhosis and those with suspected advanced liver fibrosis. The methodology focuses on overcoming the limitations of traditional Fibroscan measurements, particularly in obese patients.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with radiologic evidence of cirrhosis and indications for variceal screening.
Not a fit: Patients with decompensated cirrhosis or those with a history of liver transplant or hepatocellular carcinoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive and more accurate method for predicting serious complications in patients with liver cirrhosis.
How similar studies have performed: While the use of EUS elastography is a relatively novel approach, studies have shown promising results in measuring liver stiffness as a predictor of complications in similar contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with radiologic features suggestive of cirrhosis on abdominal imaging studies such as transabdominal ultrasound, CT or MRI and indication for variceal screening * Patients with suspected advanced liver fibrosis as detected by Fibroscan * Patients with clinical evidence of hypersplenism * Age \> 18 years * Written informed consent available Exclusion Criteria: * Patients with features of decompensated cirrhosis, such as history of ascites, prior variceal bleeding, hepatic encephalopathy, hepatorenal syndrome * Patients with history of hepatocellular carcinoma * Patients with history of liver transplant or TIPS or shunting surgery * Patients with portal and/or mesenteric vein thrombosis * Moribund patients from terminal illnesses * Patients with terminal malignancy * Contraindications for endoscopy * Unable to provide written informed consent * Pregnancy
Where this trial is running
Sha Tin, New Territories
- Prince of Wales Hospital, The Chinese University of Hong Kong — Sha Tin, New Territories, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Raymond Tang, MD — Chinese University of Hong Kong
- Study coordinator: Thomas Lam, BS
- Email: thomaslam@cuhk.edu.hk
- Phone: 852-3505-3509
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.