Clinical trial NCT03778775: Transient Elastography (FibroTouch) for Assessing Risk of Gastroesophageal Varices Bleeding in Compensated Cirrhosis (Pan-CHESS1801)
Official title: Transient Elastography (FibroTouch) for Assessing Risk of Gastroesophageal Varices Bleeding in Patients With Compensated Cirrhosis (Pan-CHESS1801): An International Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Compensated Liver Cirrhosis
Gastroesophageal Varices Bleeding
Keywords: Transient elastography
Gastroesophageal varices bleeding
Varices needing treatment
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Beijing Tsinghua Changgeng Hospital
name: LanZhou University
name: Beijing 302 Hospital
name: Xijing Hospital of Digestive Diseases
name: Wuhan Union Hospital, China
name: Zhujiang Hospital
name: Second Affiliated Hospital of Xi'an Jiaotong University
name: The Central Hospital of Lishui City
name: Xingtai People's Hospital
name: Seventh Medical Center of PLA Army General Hospital
name: Shandong Provincial Hospital
name: Southern Medical University, China
name: Medistra Hospital, University of Indonesia
name: Ankara University
name: Osaka City University
name: Chulalongkorn University
First posted: 2018-12-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with compensated liver cirrhosis

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic accuracy of FibroTouch-based models for the risk of variceal bleeding
timeFrame: 1 day
Secondary outcomes:
measure: The correlation between FibroTouch-based models and HVPG
timeFrame: 1 day
measure: Diagnostic accuracy of FibroTouch-based models for the decompensated events of cirrhotic portal hypertension
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Seventh Medical Center of Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: The Fifth Medical Center of Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital of Tsinghua University
state: Beijing
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Guangzhou
country: China
facility: Zhujiang Hospital, Southern Medical University
state: Guangdong
city: Shunde
country: China
facility: Shunde Hospital, Southern Medical University
state: Guangdong
city: Xingtai
country: China
facility: Xingtai People's Hospital
state: Hebei
city: Wuhan
country: China
facility: Wuhan Union Hospital, China
state: Hubei
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shanxi
city: Xian
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Lishui
country: China
facility: The Central Hospital of Lishui City
state: Zhejiang
city: Jakarta
country: Indonesia
facility: Medistra Hospital, University of Indonesia
city: Osaka
country: Japan
facility: Osaka City University
city: Bangkok
country: Thailand
facility: Department of Medicine, Chulalongkorn University
city: Ankara
country: Turkey
facility: Ankara University School of Medicine
Study officials:
affiliation: Beijing Tsinghua Changgeng Hospital
name: Jiahong Dong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanfang Hospital, Southern Medical University
name: Xiaolong Qi, MD
role: PRINCIPAL_INVESTIGATOR
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