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

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ClinicalTrials.gov Identifier: NCT03990753
Recruitment Status : Recruiting
First Posted : June 19, 2019
Last Update Posted : June 19, 2019
Sponsor:
Collaborators:
Southern Medical University, China
LanZhou University
Zhongda Hospital, Medical School, Southeast University
Guangdong Second Provincial General Hospital
Xingtai People's Hospital
The Third Hospital of Zhenjiang Affiliated Jiangsu University
Tianjin Second People's Hospital
Zhejiang University Lishui Hospital
the Second Affiliated Hospital of Anhui Medical University
The sixth people's hospital of Shenyang
Xi’an Gaoxin Hospital
King Chulalongkorn Memorial Hospital affiliated to Chulalongkorn University
Ankara University
Information provided by (Responsible Party):
Xiaolong Qi, Nanfang Hospital of Southern Medical University

Brief 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.


Condition or disease Intervention/treatment
Compensated Cirrhosis Diagnostic Test: esophagogastroduodenoscopy

Detailed Description:

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 (The First Hospital of Lanzhou University; Zhujiang Hospital of Southern Medical University; Nanfang Hospital of Southern Medical University; Xingtai People's Hospital; Zhongda Hospital, Medical School, Southeast University; The Third People's Hospital affiliated to Jiangsu University; Guangdong Second Provincial General Hospital; Tianjin Infectious Disease Hospital; Lishui Municipal Central Hospital; The Second Hospital of Anhui Medical University; Xi'an Gaoxin Hospital; The Sixth People's Hospital of Shenyang) in China, 1 site (Ankara University School of Medicine) in Turkey and 1 site (King Chulalongkorn Memorial Hospital affiliated to Chulalongkorn University) in Thailand to evaluate the diagnostic performance of the microbiome/peptidome-based model for HRV detection in compensated cirrhosis.


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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Microbiome/Peptidome-based Model for Non-invasive Detection of High-risk Gastroesophageal Varices in Compensated Cirrhosis (CHESS1901/APPHA1901): A Prospective Multicenter Study
Actual Study Start Date : June 13, 2019
Estimated Primary Completion Date : June 12, 2020
Estimated Study Completion Date : June 12, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Overall eligible participants
Eligible participants will receive standard esophagogastroduodenoscopy and microbiome/peptidome examination.
Diagnostic Test: esophagogastroduodenoscopy
standard esophagogastroduodenoscopy




Primary Outcome Measures :
  1. Diagnostic performance of microbiome/peptidome-based model for high-risk varices [ Time Frame: 1 day ]
    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


Secondary Outcome Measures :
  1. Diagnostic performance of microbiome/peptidome-based model for decompensation or death [ Time Frame: 3 years ]
    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

  2. Diagnostic performance of microbiome/peptidome-based model for hepatic venous pressure gradient [ Time Frame: 1 day ]
    Diagnostic performance of microbiome/peptidome-based model to determine the level of hepatic venous pressure gradient



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with compensated cirrhosis
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03990753


Contacts
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Contact: Xiaolong Qi, MD +8618588602600 qixiaolong@vip.163.com

Locations
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China, Anhui
The Second Affiliated Hospital of Anhui Medical University Not yet recruiting
Hefei, Anhui, China
Contact: Xiangpeng Hu, MD         
Principal Investigator: Jun Ye, MD         
Principal Investigator: Xiangpeng Hu, MD         
China, Gansu
The First Hospital of Lanzhou University Recruiting
Lanzhou, Gansu, China
Contact: Xiaorong Mao, MD         
Principal Investigator: Xiaorong Mao, MD         
Principal Investigator: Liting Zhang, MD         
China, Guangdong
Guangdong Second Provincial General Hospital Not yet recruiting
Guangzhou, Guangdong, China
Contact: Ming Xu, MD         
Principal Investigator: Ming Xu, MD         
Sub-Investigator: Xiaofeng Li, MD         
Nanfang Hospital of Southern Medical University Not yet recruiting
Guangzhou, Guangdong, China
Contact: Jinlin Hou, MD         
Principal Investigator: Jinlin Hou, MD         
Zhujiang Hospital of Southern Medical University Not yet recruiting
Guangzhou, Guangdong, China
Contact: Hua Mao, MD         
Principal Investigator: Hua Mao, MD         
China, Hebei
Xingtai People's Hospital Not yet recruiting
Xingtai, Hebei, China
Contact: Qingge Zhang, MD         
Principal Investigator: Qingge Zhang, MD         
Sub-Investigator: Jitao Wang, MD         
China, Jiangsu
Zhongda Hospital, Medical School, Southeast University Not yet recruiting
Nanjing, Jiangsu, China
Contact: Ruihua Shi, MD         
Principal Investigator: Ruihua Shi, MD         
The Third Hospital of Zhenjiang Affiliated Jiangsu University Not yet recruiting
Zhenjiang, Jiangsu, China
Contact: Youwen Tan, MD         
Principal Investigator: Youwen Tan, MD         
China, Liaoning
The Sixth People's Hospital of Shenyang Not yet recruiting
Shenyang, Liaoning, China
Contact: Yiying Song, MD         
Principal Investigator: Yiying Song, MD         
China, Shanxi
Xi'an Gaoxin Hospital Not yet recruiting
Xi'an, Shanxi, China
Contact: Ying Song, MD         
Principal Investigator: Ying Song, MD         
Sub-Investigator: Bojiang Zhang, MD         
China, Tianjin
Tianjin Second People's Hospital Not yet recruiting
Tianjin, Tianjin, China
Contact: Jia Li, MD         
Principal Investigator: Jia Li, MD         
Principal Investigator: Ping Li, MD         
China, Zhejiang
Zhejiang University Lishui Hospital Not yet recruiting
Lishui, Zhejiang, China
Contact: Jiansong Ji, MD         
Principal Investigator: Jiansong Ji, MD         
Sub-Investigator: Zhongwei Zhao, MD         
Thailand
King Chulalongkorn Memorial Hospital affiliated to Chulalongkorn University Not yet recruiting
Bangkok, Thailand
Contact: Sombat Treeprasertsuk, MD         
Principal Investigator: Sombat Treeprasertsuk, MD         
Turkey
Ankara University School of Medicine Not yet recruiting
Ankara, Turkey
Contact: Necati Örmeci, MD         
Principal Investigator: Necati Örmeci, MD         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Southern Medical University, China
LanZhou University
Zhongda Hospital, Medical School, Southeast University
Guangdong Second Provincial General Hospital
Xingtai People's Hospital
The Third Hospital of Zhenjiang Affiliated Jiangsu University
Tianjin Second People's Hospital
Zhejiang University Lishui Hospital
the Second Affiliated Hospital of Anhui Medical University
The sixth people's hospital of Shenyang
Xi’an Gaoxin Hospital
King Chulalongkorn Memorial Hospital affiliated to Chulalongkorn University
Ankara University
Investigators
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Principal Investigator: Hongwei Zhou, PhD Southern Medical University, China
Principal Investigator: Xiaolong Qi, MD LanZhou University

Publications:

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Responsible Party: Xiaolong Qi, Professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03990753     History of Changes
Other Study ID Numbers: CHESS1901
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xiaolong Qi, Nanfang Hospital of Southern Medical University:
Microbiome/Peptidome
High-risk Gastroesophageal Varices
Compensated Cirrhosis

Additional relevant MeSH terms:
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Fibrosis
Liver Cirrhosis
Esophageal and Gastric Varices
Pathologic Processes
Liver Diseases
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Hypertension, Portal