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

Sponsor
Nanfang Hospital of Southern Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03778775
Collaborator
Beijing Tsinghua Changgeng Hospital (Other), LanZhou University (Other), Beijing 302 Hospital (Other), Xijing Hospital of Digestive Diseases (Other), Wuhan Union Hospital, China (Other), Zhujiang Hospital (Other), Second Affiliated Hospital of Xi'an Jiaotong University (Other), The Central Hospital of Lishui City (Other), Xingtai People's Hospital (Other), Seventh Medical Center of PLA Army General Hospital (Other), Shandong Provincial Hospital (Other), Shunde Hospital, Southern Medical University (Other), Medistra Hospital, University of Indonesia (Other), Ankara University (Other), Osaka City University (Other), Chulalongkorn University (Other)
200
Enrollment
16
Locations
38.9
Anticipated Duration (Months)
12.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Liver sitffness measurement

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Transient Elastography (FibroTouch) for Assessing Risk of Gastroesophageal Varices Bleeding in Patients With Compensated Cirrhosis (Pan-CHESS1801): An International Multicenter Study
Actual Study Start Date :
Dec 14, 2018
Actual Primary Completion Date :
Jun 13, 2021
Anticipated Study Completion Date :
Mar 13, 2022

Arms and Interventions

Arm Intervention/Treatment
Overall eligible participants

Eligible participants will receive standard esophagogastroduodenoscopy and liver stiffness measurement by FibroTouch.

Diagnostic Test: Liver sitffness measurement
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.
Other Names:
  • Esophagogastroduodenoscopy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. The correlation between FibroTouch-based models and HVPG [1 day]

      The correlation between FibroTouch-based models and hepatic venous pressure gradient (HVPG)

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Seventh Medical Center of Chinese PLA General Hospital Beijing Beijing China 100000
    2 The Fifth Medical Center of Chinese PLA General Hospital Beijing Beijing China 100039
    3 Beijing Tsinghua Changgung Hospital of Tsinghua University Beijing Beijing China 102218
    4 The First Hospital of Lanzhou University Lanzhou Gansu China
    5 Zhujiang Hospital, Southern Medical University Guangzhou Guangdong China 510000
    6 Shunde Hospital, Southern Medical University Shunde Guangdong China
    7 Xingtai People's Hospital Xingtai Hebei China
    8 Wuhan Union Hospital, China Wuhan Hubei China 430022
    9 Shandong Provincial Hospital Jinan Shandong China
    10 Xijing Hospital of Digestive Diseases Xi'an Shanxi China
    11 The Second Affiliated Hospital of Xi'an Jiaotong University Xian Shanxi China
    12 The Central Hospital of Lishui City Lishui Zhejiang China
    13 Medistra Hospital, University of Indonesia Jakarta Indonesia
    14 Osaka City University Osaka Japan
    15 Department of Medicine, Chulalongkorn University Bangkok Thailand
    16 Ankara University School of Medicine Ankara Turkey

    Sponsors and Collaborators

    • Nanfang Hospital of Southern Medical University
    • Beijing Tsinghua Changgeng Hospital
    • LanZhou University
    • Beijing 302 Hospital
    • Xijing Hospital of Digestive Diseases
    • Wuhan Union Hospital, China
    • Zhujiang Hospital
    • Second Affiliated Hospital of Xi'an Jiaotong University
    • The Central Hospital of Lishui City
    • Xingtai People's Hospital
    • Seventh Medical Center of PLA Army General Hospital
    • Shandong Provincial Hospital
    • Shunde Hospital, Southern Medical University
    • Medistra Hospital, University of Indonesia
    • Ankara University
    • Osaka City University
    • Chulalongkorn University

    Investigators

    • Principal Investigator: Jiahong Dong, MD, Beijing Tsinghua Changgeng Hospital
    • Principal Investigator: Xiaolong Qi, MD, Nanfang Hospital of Southern Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Xiaolong Qi, Director, Hepatic Hemodynamic Lab, Nanfang Hospital of Southern Medical University
    ClinicalTrials.gov Identifier:
    NCT03778775
    Other Study ID Numbers:
    • Pan-CHESS1801
    First Posted:
    Dec 19, 2018
    Last Update Posted:
    Aug 17, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xiaolong Qi, Director, Hepatic Hemodynamic Lab, Nanfang Hospital of Southern Medical University
    Transient elastography
    Gastroesophageal varices bleeding
    Varices needing treatment
    Additional relevant MeSH terms:
    Liver Cirrhosis
    Esophageal and Gastric Varices
    Varicose Veins
    Hemorrhage
    Fibrosis

    Study Results

    No Results Posted as of Aug 17, 2021