Microbiome/Peptidome-based Model for Non-invasive Detection of High-risk Gastroesophageal Varices in Compensated Cirrhosis (CHESS1901/APPHA1901)

Summary

Variceal hemorrhage is a lethal complication in patients with cirrhosis and portal hypertension. Identification of varices needing treatment in compensated cirrhosis is, therefore, of great therapeutic and prognostic importance. The gold standard for diagnosing gastroesophageal varices and evaluating the risk of variceal hemorrhage is esophagogastroduodenoscopy. According to the Baveno VI consensus, for those with high-risk varices (HRV), 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 use in clinical practice, especially in patients with compensated cirrhosis. Sufficient accurate non-invasive tools for detection of HRV are warranted to safely avoid the use of esophagogastroduodenoscopy.

Advanced technologies including next-generation sequencing and MALDI-TOF mass spectrometry have the potential to be applied in this field. The latter is a widespread adopted tool in clinical microbiology for rapid, accurate and cost-effective identification of cultured bacteria and fungi. Recently, microbiome and peptidome have been proved their roles in the end-stage liver disease (e.g. cirrhosis, hepatocellular carcinoma), which may exhibit predictive capacity of HRV. In the present study, the investigators aim to conduct a prospective, multicenter diagnostic trial in 12 sites in China, 1 site in Turkey and 1 site in Thailand to evaluate the diagnostic performance of the microbiome/peptidome-based model for HRV detection in compensated cirrhosis.

Conditions

• Compensated Cirrhosis

Interventions

DIAGNOSTIC_TEST

esophagogastroduodenoscopy

standard esophagogastroduodenoscopy

Sponsors & Collaborators

• Southern Medical University, China

  collaborator OTHER

• LanZhou University

  collaborator OTHER

• Zhongda Hospital

  collaborator OTHER

• Guangdong Second Provincial General Hospital

  collaborator OTHER

• Xingtai People's Hospital

  collaborator OTHER

• The Third Hospital of Zhenjiang Affiliated Jiangsu University

  collaborator UNKNOWN

• Tianjin Second People's Hospital

  collaborator OTHER

• Zhejiang University Lishui Hospital

  collaborator UNKNOWN

• The Second Hospital of Anhui Medical University

  collaborator OTHER

• The Sixth People's Hospital of Shenyang

  collaborator OTHER

• Xi'an Gaoxin Hospital

  collaborator OTHER

• King Chulalongkorn Memorial Hospital affiliated to Chulalongkorn University

  collaborator UNKNOWN

• Ankara University

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  lead OTHER

Principal Investigators

• Hongwei Zhou, PhD · Southern Medical University, China

• Xiaolong Qi, MD · LanZhou University

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-13

Primary Completion

2021-06-12

Completion

2022-06-12

Countries

• China
• Thailand
• Turkey (Türkiye)

Study Locations