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

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.

Conditions

• Compensated Liver Cirrhosis
• Gastroesophageal Varices Bleeding

Interventions

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.

Sponsors & Collaborators

• Beijing Tsinghua Changgeng Hospital

  collaborator OTHER

• LanZhou University

  collaborator OTHER

• Beijing 302 Hospital

  collaborator OTHER

• Xijing Hospital of Digestive Diseases

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Zhujiang Hospital

  collaborator OTHER

• Second Affiliated Hospital of Xi'an Jiaotong University

  collaborator OTHER

• The Central Hospital of Lishui City

  collaborator OTHER

• Xingtai People's Hospital

  collaborator OTHER

• Seventh Medical Center of PLA Army General Hospital

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• Southern Medical University, China

  collaborator OTHER

• Medistra Hospital, University of Indonesia

  collaborator UNKNOWN

• Ankara University

  collaborator OTHER

• Osaka City University

  collaborator OTHER

• Chulalongkorn University

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  lead OTHER

Principal Investigators

• Jiahong Dong, MD · Beijing Tsinghua Changgeng Hospital

• Xiaolong Qi, MD · Nanfang Hospital, Southern Medical University

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-12-14

Primary Completion

2021-06-13

Completion

2022-03-13

Countries

• China
• Indonesia
• Japan
• Thailand
• Turkey (Türkiye)

Study Locations