An observational study in Liver Cirrhosis, Liver Fibrosis and Portal Hypertension, sponsored by Fifth Affiliated Hospital, Sun Yat-Sen University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by Fifth Affiliated Hospital, Sun Yat-Sen University · Observational
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.
Patients with chronic liver disease who visit Fifth Affiliated Hospital, Sun Yat-Sen University will be enrolled from October 2023 to January 2025. Their liver stiffness measured by transient elastography (TE) should be at least 10 kilopascal (kPa) and with no previous decompensation symptoms.
Patients will be asked to sign an informed consent form. After that, researchers will assess the eligibility of the participants according to inclusion and exclusion criteria, and record their demographic data, history of disease, and the etiology of liver disease.
The participants will be required to complete relevant laboratory tests such as blood routine, liver function, kidney function, coagulation function and etiology. After completing the tests, the results will be recorded by primary researchers.
Abdominal ultrasound and 2D-shear wave elastography (2D-SWE) will be conducted by a sonographer, the interval between ultrasonic examination and laboratory tests should be less than a week, and the patients should fast for at least 4 hours before the examination. Abdominal ultrasound findings, liver stiffness, spleen stiffness, spleen thickness, spleen diameter, portal vein trunk diameter will be recorded by primary researchers.
TE examination will be conducted by experienced nurses, instructing patients to have a fasting period of at least 4 hours prior to the tests. An interval of no more than 1 week should separate the abdominal ultrasound and 2D-SWE examination. The report will be considered highly reliable only if the interquartile range to median ratio (IQR/med) is ≤ 30%, at least 10 successful acquisitions are obtained, and the success rate is at least 60%. Liver stiffness, spleen stiffness and controlled attenuation parameter (CAP) will be recorded by primary researchers.
Gastroscopy will be conducted and reported by experienced endoscopists. There should be a maximum interval of no more than 1 month between the gastroscopy and ultrasound examination, and patients should fast for at least 8 hours before undergoing gastroscopy. Primary researchers will record the site of varices veins, their maximum diameter, risk factors, risk levels, and the determination of whether they are high-risk varices or not.
Demographic characteristics and laboratory results will be collected to describe participants' condition, and the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the receiver operating characteristic (AUROC) of 2D-SWE will be compared with that of TE in diagnosing GOV, and the cut-off value of 2D-SWE for diagnosing GOV will be explored.
1,668 studies on the registry are indexed under Liver Cirrhosis; 360 are open to participants now.
This study's planned enrollment of 150 is close to the median of 152 across 605 observational studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Fifth Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 58 studies on the registry; 20 are open to participants now.
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Patients with chronic liver disease who visit Fifth Affiliated Hospital, Sun Yat-Sen University will be enrolled from October 2023 to January 2025. Their liver stiffness measured by transient elastography (TE) should be at least 10kPa no previous decompensation symptoms.
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Exclusion Criteria:
All participants included will be in one study group.
Diagnostic Test: Transient elastography (TE) and 2D-shear wave elastography (2D-SWE)
Index test: TE examination will be completed by experienced nurses, requiring fasting for more than 4 hours before the examination and an interval of no more than 1 week from the abdominal ultrasound and 2D-SWE examination. The report will be considered highly reliable only if IQR/med is ≤ 30%, at least 10 successful acquisitions are obtained, and the success rate is at least 60%. Abdominal ultrasound and 2D-shear wave elastography (2D-SWE) will be completed by a sonographer, the interval between ultrasonic examination and laboratory tests should be less than a week, and the patients should fast for at least 4 hours before the examination. Reference standard: Gastroscopy will be completed and reported by experienced endoscopists, requiring no more than 1 month between gastroscopy and ultrasound examination, and patients should fast for at least 8 hours before gastroscopy.
Sensitivity of TE and 2D-SWE
True Positive/ (True Positive+False Negative) ×100%
Time frame: Through study completion, an average of 2 year
Specificity of TE and 2D-SWE
True Negative/ (True Negative+False Positive) ×100%
Time frame: Through study completion, an average of 2 year
Positive Predictive Value of TE and 2D-SWE
True Positive/ (True Positive+False Positive) ×100%
Time frame: Through study completion, an average of 2 year
Negative Predictive Value of TE and 2D-SWE
True Negative/ (True Negative+False Negative) ×100%
Time frame: Through study completion, an average of 2 year
Overall diagnostic performance of TE and 2D-SWE
Measured by the area under the receiver operating characteristic curve (AUROC). The test accuracy level is considered high when the AUROC value is ≥ 0.9.
Time frame: Through study completion, an average of 2 year
Plan to share: No — The datasets generated during and/or analysed during the current study will be available from the principal investigator on reasonable request.
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This study is status unknown, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Fifth Affiliated Hospital, Sun Yat-Sen University