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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Compensated Liver Cirrhosis; Gastroesophageal Varices Bleeding
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Xiaolong Qi, MD; Phone Number: 18588602600; Email: qixiaolong@vip.163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • The Seventh Medical Center of Chinese PLA General Hospital
      • Contact: Shuai Wang, M.D.
      • Principal Investigator: Shuai Wang, M.D.
      • Sub-Investigator: Yasong Li, M.D.
    • Beijing, Beijing, China, 100039
      • Not yet recruiting
      • The Fifth Medical Center of Chinese PLA General Hospital
      • Contact: Guofeng Chen
      • Principal Investigator: Guofeng Chen, M.D.
      • Sub-Investigator: Dong Ji, M.D.
    • Beijing, Beijing, China, 102218
      • Not yet recruiting
      • Beijing Tsinghua Changgung Hospital of Tsinghua University
      • Principal Investigator: Jiahong Dong, M.D.
      • Sub-Investigator: Lin Zhang, M.D.
  • Gansu
    • Lanzhou, Gansu, China
      • Not yet recruiting
      • The First Hospital of Lanzhou University
      • Principal Investigator: Xun Li, M.D.
      • Contact: Xiaorong Mao, M.D.
      • Sub-Investigator: Xiaorong Mao, M.D.
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Zhujiang Hospital, Southern Medical University
      • Contact: Hua Mao
      • Principal Investigator: Hua Mao, M.D.
    • Shunde, Guangdong, China
      • Not yet recruiting
      • Shunde Hospital, Southern Medical University
      • Contact: Guoping Du, M.D.
      • Principal Investigator: Guoping Du, M.D.
  • Hebei
    • Xingtai, Hebei, China
      • Not yet recruiting
      • Xingtai People's Hospital
      • Contact: Dengxiang Liu, M.D.
      • Principal Investigator: Dengxiang Liu, M.D.
      • Sub-Investigator: Qingge Zhang, M.D.
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Not yet recruiting
      • Wuhan Union Hospital, China
      • Contact: Ling Yang, M.D.
      • Principal Investigator: Xiaohua Hou, M.D.
      • Sub-Investigator: Ling Yang, M.D.
  • Shandong
    • Jinan, Shandong, China
      • Not yet recruiting
      • Shandong Provincial Hospital
      • Principal Investigator: Chunqing Zhang, M.D.
  • Shanxi
    • Xi'an, Shanxi, China
      • Not yet recruiting
      • Xijing Hospital of Digestive Diseases
      • Contact: Ying Han, M.D.
      • Principal Investigator: Ying Han, M.D.
    • Xian, Shanxi, China
      • Not yet recruiting
      • The Second Affiliated Hospital of Xi'an Jiaotong University
      • Contact: Zongfang Li, M.D.
      • Principal Investigator: Zongfang Li, M.D.
      • Sub-Investigator: Fanpu Ji, M.D.
  • Zhejiang
    • Lishui, Zhejiang, China
      • Not yet recruiting
      • The Central Hospital of Lishui City
      • Contact: Jiansong Ji, M.D.
      • Principal Investigator: Jiansong Ji, M.D.
      • Sub-Investigator: Zhongwei Zhao, M.D.
• Indonesia
  • Jakarta, Indonesia
    • Not yet recruiting
    • Medistra Hospital, University of Indonesia
    • Principal Investigator: Cosmas Rinaldi A. Lesmana, M.D.
• Japan
  • Osaka, Japan
    • Not yet recruiting
    • Osaka City University
    • Contact: Norifumi Kawada, M.D.
    • Principal Investigator: Norifumi Kawada, M.D.
• Thailand
  • Bangkok, Thailand
    • Not yet recruiting
    • Department of Medicine, Chulalongkorn University
    • Contact: Sombat Treeprasertsuk, M.D.
    • Principal Investigator: Sombat Treeprasertsuk, M.D.
• Turkey
  • Ankara, Turkey
    • Not yet recruiting
    • Ankara University School of Medicine
    • Principal Investigator: Necati Örmeci, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants with compensated liver cirrhosis

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Qi X, Berzigotti A, Cardenas A, Sarin SK. Emerging non-invasive approaches for diagnosis and monitoring of portal hypertension. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):708-719. doi: 10.1016/S2468-1253(18)30232-2.
• Wang FS, Fan JG, Zhang Z, Gao B, Wang HY. The global burden of liver disease: the major impact of China. Hepatology. 2014 Dec;60(6):2099-108. doi: 10.1002/hep.27406. Epub 2014 Oct 29.
• de Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available.
• Berzigotti A, Seijo S, Arena U, Abraldes JG, Vizzutti F, Garcia-Pagan JC, Pinzani M, Bosch J. Elastography, spleen size, and platelet count identify portal hypertension in patients with compensated cirrhosis. Gastroenterology. 2013 Jan;144(1):102-111.e1. doi: 10.1053/j.gastro.2012.10.001. Epub 2012 Oct 8.
• Liu F, Ning Z, Liu Y, Liu D, Tian J, Luo H, An W, Huang Y, Zou J, Liu C, Liu C, Wang L, Liu Z, Qi R, Zuo C, Zhang Q, Wang J, Zhao D, Duan Y, Peng B, Qi X, Zhang Y, Yang Y, Hou J, Dong J, Li Z, Ding H, Zhang Y, Qi X. Development and validation of a radiomics signature for clinically significant portal hypertension in cirrhosis (CHESS1701): a prospective multicenter study. EBioMedicine. 2018 Oct;36:151-158. doi: 10.1016/j.ebiom.2018.09.023. Epub 2018 Sep 27.
• Bhardwaj A, Kedarisetty CK, Vashishtha C, Bhadoria AS, Jindal A, Kumar G, Choudhary A, Shasthry SM, Maiwall R, Kumar M, Bhatia V, Sarin SK. Carvedilol delays the progression of small oesophageal varices in patients with cirrhosis: a randomised placebo-controlled trial. Gut. 2017 Oct;66(10):1838-1843. doi: 10.1136/gutjnl-2016-311735. Epub 2016 Jun 13.
• Zhu Q, Wang W, Zhao J, Al-Asbahi AAM, Huang Y, Du F, Zhou J, Song Y, Xu K, Ye J, Yang L. Transient Elastography Identifies the Risk of Esophageal Varices and Bleeding in Patients With Hepatitis B Virus-Related Liver Cirrhosis. Ultrasound Q. 2018 Sep;34(3):141-147. doi: 10.1097/RUQ.0000000000000373.
• Qi X, An W, Liu F, Qi R, Wang L, Liu Y, Liu C, Xiang Y, Hui J, Liu Z, Qi X, Liu C, Peng B, Ding H, Yang Y, He X, Hou J, Tian J, Li Z. Virtual Hepatic Venous Pressure Gradient with CT Angiography (CHESS 1601): A Prospective Multicenter Study for the Noninvasive Diagnosis of Portal Hypertension. Radiology. 2019 Feb;290(2):370-377. doi: 10.1148/radiol.2018180425. Epub 2018 Nov 20.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 14, 2018
• Primary Completion (ACTUAL): June 13, 2021
• Study Completion (ANTICIPATED): March 13, 2022

Study Registration Dates

• First Submitted: December 16, 2018
• First Submitted That Met QC Criteria: December 16, 2018
• First Posted (ACTUAL): December 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Transient elastography; Varices needing treatment; Gastroesophageal varices bleeding
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Liver Diseases; Esophageal Diseases; Hypertension, Portal; Fibrosis; Hemorrhage; Liver Cirrhosis; Esophageal and Gastric Varices; Varicose Veins
• Other Study ID Numbers: Pan-CHESS1801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided.

Drug and device information, study documents

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