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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Cirrhosis; Portal Hypertension; Liver Fibrosis
• Intervention / Treatment: Diagnostic test: Transient elastography (TE) and 2D-shear wave elastography (2D-SWE)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Xi Liu, PhD; Phone Number: +86 15992670630; Email: liuxi26@mail.sysu.edu.cn
• Study Contact Backup: Name: Chenyue Jin, BMed; Phone Number: +86 18025084237; Email: jinchy5@mail2.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Zhuhai, Guangdong, China, 519000
      • Recruiting
      • The Fifth Affiliated Hospital, Sun Yat-sen University
      • Contact: Xi Liu, PhD; Phone Number: +86 15992670630; Email: liuxi26@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

study group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of TE and 2D-SWE	True Positive/ (True Positive+False Negative) ×100%	Through study completion, an average of 2 year
Specificity of TE and 2D-SWE	True Negative/ (True Negative+False Positive) ×100%	Through study completion, an average of 2 year
Positive Predictive Value of TE and 2D-SWE	True Positive/ (True Positive+False Positive) ×100%	Through study completion, an average of 2 year
Negative Predictive Value of TE and 2D-SWE	True Negative/ (True Negative+False Negative) ×100%	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.	Through study completion, an average of 2 year

Collaborators and Investigators

• Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
• Investigators: Principal Investigator: Xi Liu, PhD, The Fifth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: November 12, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Liver Cirrhosis; Liver Stiffness; Spleen Stiffness; 2D-SWE; Gastroesophageal Varices
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis; Hypertension, Portal
• Other Study ID Numbers: ZDWY.GRBK.034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The datasets generated during and/or analysed during the current study will be available from the principal investigator on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No