Transient Elastography (FibroTouch) for Assessing Risk of Gastroesophageal Varices Bleeding in Compensated Cirrhosis (Pan-CHESS1801)

Study Overview
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Brief Summary
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Gastroesophageal varices occurs in approximately half of the patients with liver cirrhosis. Variceal bleeding is the most common lethal complication directly from cirrhotic portal hypertension. The golden standard for diagnosing gastroesophageal varices and evaluating the risk of variceal bleeding is the esophagogastroduodenoscopy. According to the Baveno VI consensus, for those with high-risk varices (varies needing treatment), either non-selective beta blockers or endoscopic band ligation is recommended for the prevention of the first variceal bleeding. However, the invasiveness and uncomfortableness during the esophagogastroduodenoscopy procedure has hindered its routine use in clinical practice, especially in compensated cirrhotic patients. The important role of transient elastography for defining the presence of high-risk varices was highlighted in the Baveno VI consensus workshop that cirrhotic patients with a liver stiffness measurement (LSM) of less than 20 kPa and a platelet count of greater than 150,000/μL can avoid screening endoscopy. In addition, transient elastography-based models (e.g. LSM combined with platelet count, liver stiffness spleen diameter-to-platelet score) were shown to have potentials in distinguish the absence of high-risk gastroesophageal varices. However, this cutoff value of LSM was validated mainly in cohorts with alcoholic or hepatitis C virus dominated cirrhosis. The unmet need is a precise cutoff to rule out high-risk varices in hepatitis B virus dominated cirrhosis, which is an outstanding issue in Asia-Pacific population. FibroTouch (Hisky Medical Technologies Co. Ltd, Wuxi, China) is a new-generation of transient elastography based on a two-dimensional image-guided system to ensure the precise orientation. In the present study, the investigators aim to conduct an international prospective diagnostic trial with 16 sites to develop and validate the diagnostic performance of FibroTouch-based models for assessing risk of gastroesophageal varices bleeding in compensated cirrhosis.

Detailed Description
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Gastroesophageal varices occurs in approximately half of the patients with liver cirrhosis. Variceal bleeding is the most common lethal complication directly from cirrhotic portal hypertension. The golden standard for diagnosing gastroesophageal varices and evaluating the risk of variceal bleeding is the esophagogastroduodenoscopy. According to the Baveno VI consensus, for those with high-risk varices (varies needing treatment), either non-selective beta blockers or endoscopic band ligation is recommended for the prevention of the first variceal bleeding. However, the invasiveness and uncomfortableness during the esophagogastroduodenoscopy procedure has hindered its routine use in clinical practice, especially in compensated cirrhotic patients. The important role of transient elastography for defining the presence of high-risk varices was highlighted in the Baveno VI consensus workshop that cirrhotic patients with a liver stiffness measurement (LSM) of less than 20 kPa and a platelet count of greater than 150,000/μL can avoid screening endoscopy. In addition, transient elastography-based models (e.g. LSM combined with platelet count, liver stiffness spleen diameter-to-platelet score) were shown to have potentials in distinguish the absence of high-risk gastroesophageal varices. However, this cutoff value of LSM was validated mainly in cohorts with alcoholic or hepatitis C virus dominated cirrhosis. The unmet need is a precise cutoff to rule out high-risk varices in hepatitis B virus dominated cirrhosis, which is an outstanding issue in Asia-Pacific population. FibroTouch (Hisky Medical Technologies Co. Ltd, Wuxi, China) is a new-generation of transient elastography based on a two-dimensional image-guided system to ensure the precise orientation. In the present study, the investigators aim to conduct an international prospective diagnostic trial with 16 sites (Beijing Tsinghua Changgung Hospital, Lanzhou University, The Fifth Medical Center of Chinese PLA General Hospital, Xijing Hospital of Digestive Diseases Wuhan Union Hospital, Zhujiang Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, The Central Hospital of Lishui City, Xingtai People's Hospital, The Seventh Medical Center of Chinese PLA General Hospital Shandong Provincial Hospital, Shunde Hospital, Southern Medical University Medistra Hospital; University of Indonesia, Ankara University School of Medicine, Osaka City University, Chulalongkorn University) to develop and validate the diagnostic performance of FibroTouch-based models for assessing risk of gastroesophageal varices bleeding in compensated cirrhosis.

Official Title
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Transient Elastography (FibroTouch) for Assessing Risk of Gastroesophageal Varices Bleeding in Patients With Compensated Cirrhosis (Pan-CHESS1801): An International Multicenter Study

Conditions
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Compensated Liver Cirrhosis, Gastroesophageal Varices Bleeding

Intervention / Treatment
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* Diagnostic Test: Liver sitffness measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-75 years; confirmed liver cirrhosis based on liver biopsy or clinical findings; compensated liver cirrhosis; scheduled to undergo esophagogastroduodenoscopy; estimated survival time> 24 months, and model for end-stage liver disease (MELD) score< 19; with written informed consent. Exclusion Criteria: contradictions for esophagogastroduodenoscopy; body mass index> 35 kg/m2; presence of decompensation events (e.g. ascites, variceal bleeding, hepatic encephalopathy, etc.); previous esophageal variceal banding legation or transjugular intrahepatic portosystemic shunt; current use of non-selective beta-blockers; with portal vein thrombosis or hepatocellular carcinoma; non-cirrhotic portal hypertension; pregnancy or unknown pregnancy status.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Overall eligible participants<br>Eligible participants will receive standard esophagogastroduodenoscopy and liver stiffness measurement by FibroTouch. | Diagnostic Test: Liver sitffness measurement<br>* Liver sitffness measurement is performed by FibroTouch, a new-generation of transient elastography with the tesing interval between liver sitffness measurement and esophagogastroduodenoscopy less than one week.<br>* Other names: Esophagogastroduodenoscopy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of FibroTouch-based models for the risk of variceal bleeding | Diagnostic accuracy of FibroTouch-based models to determine the high-risk or low-risk of variceal bleeding with esophagogastroduodenoscopy as the reference standard | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The correlation between FibroTouch-based models and HVPG | The correlation between FibroTouch-based models and hepatic venous pressure gradient (HVPG) | 1 day | 
| Diagnostic accuracy of FibroTouch-based models for the decompensated events of cirrhotic portal hypertension | Diagnostic accuracy of FibroTouch-based models to determine the presence or absence of decompensated events (e.g. first variceal bleeding) within 1-year follow-up | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transient elastography, Gastroesophageal varices bleeding, Varices needing treatment