UnknownNot Applicable

Liver and Spleen Stiffness Measured by TE and 2D-SWE for Diagnosis of GOV in Patients With cACLD

China150 participantsStarted 2023-11-01

Plain-language summary

A observational diagnostic study will be conducted to compare the performance of liver stiffness and spleen stiffness measured by 2D-shear wave elastography (2D-SWE) and transient elastography (TE) for diagnosing gastroesophageal varices (GOV) in people with compensated Advanced Chronic Liver Disease (cACLD), and explore the cut-off value of 2D-SWE for diagnosing GOV.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sensitivity of TE and 2D-SWE

Timeframe: Through study completion, an average of 2 year

Specificity of TE and 2D-SWE

Timeframe: Through study completion, an average of 2 year

Positive Predictive Value of TE and 2D-SWE

Timeframe: Through study completion, an average of 2 year

Negative Predictive Value of TE and 2D-SWE

Timeframe: Through study completion, an average of 2 year

Overall diagnostic performance of TE and 2D-SWE

Timeframe: Through study completion, an average of 2 year

Trial details

NCT IDNCT06144437

SponsorFifth Affiliated Hospital, Sun Yat-Sen University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-01-01

Contact for this trial

Xi Liu, PhD

+86 15992670630 liuxi26@mail.sysu.edu.cn

View on ClinicalTrials.gov More Liver Cirrhosis trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Sensitivity of TE and 2D-SWE

Timeframe: Through study completion, an average of 2 year

Specificity of TE and 2D-SWE

Timeframe: Through study completion, an average of 2 year

Positive Predictive Value of TE and 2D-SWE

Timeframe: Through study completion, an average of 2 year

Negative Predictive Value of TE and 2D-SWE

Timeframe: Through study completion, an average of 2 year

Overall diagnostic performance of TE and 2D-SWE

Timeframe: Through study completion, an average of 2 year