Assessing liver and spleen stiffness to diagnose gastroesophageal varices in patients with chronic liver disease
Liver and Spleen Stiffness Measured by Transient Elastography and 2D-shear Wave Elastography for Diagnosis of Gastroesophageal Varices in Patients With Compensated Advanced Chronic Liver Disease: a Diagnostic Accuracy Study
This study is testing if measuring the stiffness of the liver and spleen can help doctors better diagnose gastroesophageal varices in people with advanced chronic liver disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fifth Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Locations | 1 site (Zhuhai, Guangdong) |
| Trial ID | NCT06144437 on ClinicalTrials.gov |
What this trial studies
This observational diagnostic study aims to compare the effectiveness of liver and spleen stiffness measurements using 2D-shear wave elastography (2D-SWE) and transient elastography (TE) for diagnosing gastroesophageal varices (GOV) in patients with compensated advanced chronic liver disease (cACLD). Participants will undergo a series of assessments, including demographic data collection, laboratory tests, and imaging studies, to evaluate their liver and spleen stiffness. The study will take place at the Fifth Affiliated Hospital, Sun Yat-Sen University, from October 2023 to January 2025, with a focus on establishing a cut-off value for 2D-SWE in diagnosing GOV.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic liver disease and liver stiffness of at least 10 kPa, who have not experienced any decompensation symptoms.
Not a fit: Patients with hepatocellular carcinoma, acute liver disease, or those who have undergone splenectomy or have other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the diagnostic accuracy for gastroesophageal varices in patients with chronic liver disease, potentially leading to better management and outcomes.
How similar studies have performed: Other studies have shown promise in using elastography techniques for liver assessment, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age≥18 years old; * Chronic liver disease (alcoholic liver disease, chronic hepatitis B, chronic hepatitis C or non-alcoholic fatty liver disease); * Liver stiffness ≥10kPa measured by transient elastography (TE); * No previous decompensation-related manifestations (such as ascites, gastrointestinal varicose bleeding, hepatic encephalopathy, etc.); * Informed consent has been signed. Exclusion Criteria: * Hepatocellular carcinoma or other advanced malignant tumor; * Acute liver disease or ALT≥5×ULN; * A history of splenectomy or splenic embolism; * Acute or chronic thrombosis of the portal vein; * Pregnancy or HIV infection; * A history of transjugular intrahepatic portosystemic shunts (TIPs), endoscopic variceal ligation(EVL) , hardener or tissue gel therapy; * A history of using non-selective beta blockers (NSBB) or diuretic in the last 3 months; * Persistent substance abuse other than alcohol; * There are conditions that seriously affect TE and 2D-SWE measurements (such as the intercostal space is too narrow, BMI≥30, etc.); * There are contraindications of gastroscopy (such as heart failure, severe coagulation dysfunction, hepatic encephalopathy, etc.); * Subjects considered unsuitable for including in this study but not included by the above exclusion criteria.
Where this trial is running
Zhuhai, Guangdong
- The Fifth Affiliated Hospital, Sun Yat-sen University — Zhuhai, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Xi Liu, PhD — The Fifth Affiliated Hospital, Sun Yat-sen University
- Study coordinator: Xi Liu, PhD
- Email: liuxi26@mail.sysu.edu.cn
- Phone: +86 15992670630
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.