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

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

Sponsors

Lead sponsor: Nanfang Hospital of Southern Medical University

Collaborator: Beijing Tsinghua Changgung Hospital of Tsinghua University
LanZhou University
The Fifth Medical Center of Chinese PLA General 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
The Seventh Medical Center of Chinese PLA General Hospital
Shandong Provincial Hospital
Shunde Hospital, Southern Medical University
Medistra Hospital, University of Indonesia
Ankara University
Osaka City University
Chulalongkorn University

Source Nanfang Hospital of 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.

Overall Status Recruiting
Start Date December 14, 2018
Completion Date October 13, 2020
Primary Completion Date October 13, 2019
Study Type Observational
Primary Outcome
Measure Time Frame
Diagnostic accuracy of FibroTouch-based models for the risk of variceal bleeding 1 day
Secondary Outcome
Measure Time Frame
The correlation between FibroTouch-based models and HVPG 1 day
Diagnostic accuracy of FibroTouch-based models for the decompensated events of cirrhotic portal hypertension 1 year
Enrollment 200
Condition
Intervention

Intervention type: Diagnostic Test

Intervention name: Liver sitffness measurement

Description: 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.

Arm group label: Overall eligible participants

Other name: Esophagogastroduodenoscopy

Eligibility

Sampling method: Non-Probability Sample

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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Overall Contact

Last name: Xiaolong Qi, MD

Phone: 18588602600

Email: [email protected]

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

China

Indonesia

Japan

Thailand

Turkey

Verification Date

December 2018

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Nanfang Hospital of Southern Medical University

Investigator full name: Xiaolong Qi

Investigator title: Director, Hepatic Hemodynamic Lab

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Overall eligible participants

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

Patient Data Undecided
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov