Compensated Cirrhosis Clinical Trial
Official title:
Microbiome/Peptidome-based Model for Non-invasive Detection of High-risk Gastroesophageal Varices in Compensated Cirrhosis (CHESS1901/APPHA1901): A Prospective Multicenter Study
NCT number | NCT03990753 |
Other study ID # | CHESS1901 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 13, 2019 |
Est. completion date | June 12, 2022 |
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.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | June 12, 2022 |
Est. primary completion date | June 12, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - age 18-75 years; - confirmed compensated cirrhosis based on liver biopsy or clinical findings; - without decompensated events (e.g. ascites, bleeding, or overt encephalopathy); - scheduled to undergo esophagogastroduodenoscopy; - estimated survival time> 24 months, and model for end-stage liver disease (MELD) score< 19, and without liver transplant; - with written informed consent. Exclusion Criteria: - contradictions for esophagogastroduodenoscopy; - use of antibiotics, prebiotics, probiotics and proton pump inhibitors within 3 months upon recruitment. - pregnancy or unknown pregnancy status. |
Country | Name | City | State |
---|---|---|---|
China | Guangdong Second Provincial General Hospital | Guangzhou | Guangdong |
China | Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong |
China | Zhujiang Hospital of Southern Medical University | Guangzhou | Guangdong |
China | The Second Affiliated Hospital of Anhui Medical University | Hefei | Anhui |
China | The First Hospital of Lanzhou University | Lanzhou | Gansu |
China | Zhejiang University Lishui Hospital | Lishui | Zhejiang |
China | Zhongda Hospital, Medical School, Southeast University | Nanjing | Jiangsu |
China | The Sixth People's Hospital of Shenyang | Shenyang | Liaoning |
China | Tianjin Second People's Hospital | Tianjin | Tianjin |
China | Xi'an Gaoxin Hospital | Xi'an | Shanxi |
China | Xingtai People's Hospital | Xingtai | Hebei |
China | The Third Hospital of Zhenjiang Affiliated Jiangsu University | Zhenjiang | Jiangsu |
Thailand | King Chulalongkorn Memorial Hospital affiliated to Chulalongkorn University | Bangkok | |
Turkey | Ankara University School of Medicine | Ankara |
Lead Sponsor | Collaborator |
---|---|
Nanfang Hospital of Southern Medical University | Ankara University, Guangdong Second Provincial General Hospital, King Chulalongkorn Memorial Hospital affiliated to Chulalongkorn University, LanZhou University, Southern Medical University, China, The Second Hospital of Anhui Medical University, The Sixth People's Hospital of Shenyang, The Third Hospital of Zhenjiang Affiliated Jiangsu University, Tianjin Second People's Hospital, Xi'an Gaoxin Hospital, Xingtai People's Hospital, Zhejiang University Lishui Hospital, Zhongda Hospital, Medical School, Southeast University |
China, Thailand, Turkey,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic performance of microbiome/peptidome-based model for high-risk varices | Diagnostic performance of microbiome/peptidome-based model to determine the presence or absence of high-risk varices when compared with esophagogastroduodenoscopy as the reference standard | 1 day | |
Secondary | Diagnostic performance of microbiome/peptidome-based model for decompensation or death | Diagnostic performance of microbiome/peptidome-based model to determine the presence or absence of decompensation (defined as development of ascites, bleeding, or overt encephalopathy) or death within 3-year follow-up | 3 years | |
Secondary | Diagnostic performance of microbiome/peptidome-based model for hepatic venous pressure gradient | Diagnostic performance of microbiome/peptidome-based model to determine the level of hepatic venous pressure gradient | 1 day |
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