Transient Elastography (FibroTouch) for Assessing Risk of Gastroesophageal Varices Bleeding in Compensated Cirrhosis (Pan-CHESS1801)
- Conditions
- Compensated Liver CirrhosisGastroesophageal Varices Bleeding
- Interventions
- Diagnostic Test: Liver sitffness measurement
- Registration Number
- NCT03778775
- Lead Sponsor
- Nanfang Hospital, Southern Medical University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Overall eligible participants Liver sitffness measurement Eligible participants will receive standard esophagogastroduodenoscopy and liver stiffness measurement by FibroTouch.
- Primary Outcome Measures
Name Time Method Diagnostic accuracy of FibroTouch-based models for the risk of variceal bleeding 1 day Diagnostic accuracy of FibroTouch-based models to determine the high-risk or low-risk of variceal bleeding with esophagogastroduodenoscopy as the reference standard
- Secondary Outcome Measures
Name Time Method The correlation between FibroTouch-based models and HVPG 1 day The correlation between FibroTouch-based models and hepatic venous pressure gradient (HVPG)
Diagnostic accuracy of FibroTouch-based models for the decompensated events of cirrhotic portal hypertension 1 year 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
Trial Locations
- Locations (16)
Osaka City University
🇯🇵Osaka, Japan
Department of Medicine, Chulalongkorn University
🇹🇭Bangkok, Thailand
The Seventh Medical Center of Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
The Fifth Medical Center of Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Beijing Tsinghua Changgung Hospital of Tsinghua University
🇨🇳Beijing, Beijing, China
The First Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
Shunde Hospital, Southern Medical University
🇨🇳Shunde, Guangdong, China
Zhujiang Hospital, Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Xingtai People's Hospital
🇨🇳Xingtai, Hebei, China
Wuhan Union Hospital, China
🇨🇳Wuhan, Hubei, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
The Second Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xian, Shanxi, China
Xijing Hospital of Digestive Diseases
🇨🇳Xi'an, Shanxi, China
Ankara University School of Medicine
🇹🇷Ankara, Turkey
Medistra Hospital, University of Indonesia
🇮🇩Jakarta, Indonesia
The Central Hospital of Lishui City
🇨🇳Lishui, Zhejiang, China