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

Compensated Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03778775
• Other study ID #: Pan-CHESS1801
• Status: Recruiting
• Start date: December 14, 2018
• Est. completion date: March 13, 2022

Study information

• Verified date: August 2021
• Source: Nanfang Hospital of Southern Medical University
• Contact: Xiaolong Qi, MD
• Phone: 18588602600
• Email: qixiaolong[@]vip.163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 13, 2022
• Est. primary completion date: June 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Compensated Liver Cirrhosis
• Esophageal and Gastric Varices
• Fibrosis
• Gastroesophageal Varices Bleeding
• Hemorrhage
• Liver Cirrhosis
• Varicose Veins

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Tsinghua Changgung Hospital of Tsinghua University	Beijing	Beijing
China	The Fifth Medical Center of Chinese PLA General Hospital	Beijing	Beijing
China	The Seventh Medical Center of Chinese PLA General Hospital	Beijing	Beijing
China	Zhujiang Hospital, Southern Medical University	Guangzhou	Guangdong
China	Shandong Provincial Hospital	Jinan	Shandong
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	The Central Hospital of Lishui City	Lishui	Zhejiang
China	Shunde Hospital, Southern Medical University	Shunde	Guangdong
China	Wuhan Union Hospital, China	Wuhan	Hubei
China	Xijing Hospital of Digestive Diseases	Xi'an	Shanxi
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xian	Shanxi
China	Xingtai People's Hospital	Xingtai	Hebei
Indonesia	Medistra Hospital, University of Indonesia	Jakarta
Japan	Osaka City University	Osaka
Thailand	Department of Medicine, Chulalongkorn University	Bangkok
Turkey	Ankara University School of Medicine	Ankara

Sponsors (17)

Lead Sponsor

Collaborator

Nanfang Hospital of Southern Medical University

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

Countries where clinical trial is conducted

China,  Indonesia,  Japan,  Thailand,  Turkey, 

References & Publications (8)

Berzigotti A, Seijo S, Arena U, Abraldes JG, Vizzutti F, García-Pagán 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The correlation between FibroTouch-based models and HVPG	The correlation between FibroTouch-based models and hepatic venous pressure gradient (HVPG)	1 day
Secondary	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