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

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

Sponsoren

Hauptsponsor: Nanfang Hospital of Southern Medical University

Mitarbeiter: 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

Quelle Nanfang Hospital of Southern Medical University
Kurze Zusammenfassung

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.

detaillierte Beschreibung

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.

Gesamtstatus Recruiting
Anfangsdatum June 13, 2019
Fertigstellungstermin June 12, 2022
Primäres Abschlussdatum June 12, 2020
Studientyp Observational
Primärer Ausgang
Messen Zeitfenster
Diagnostic performance of microbiome/peptidome-based model for high-risk varices 1 day
Sekundäres Ergebnis
Messen Zeitfenster
Diagnostic performance of microbiome/peptidome-based model for decompensation or death 3 years
Diagnostic performance of microbiome/peptidome-based model for hepatic venous pressure gradient 1 day
Einschreibung 1000
Bedingung
Intervention

Interventionsart: Diagnostic Test

Interventionsname: esophagogastroduodenoscopy

Beschreibung: standard esophagogastroduodenoscopy

Armgruppenetikett: Overall eligible participants

Teilnahmeberechtigung

Probenahmeverfahren: Non-Probability Sample

Kriterien:

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.

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: 75 Years

Gesunde Freiwillige: No

Insgesamt offiziell
Gesamtkontakt

Nachname: Xiaolong Qi, MD

Telefon: +8618588602600

Email: [email protected]

Ort
Einrichtung: Status: Kontakt: Ermittler:
The Second Affiliated Hospital of Anhui Medical University | Hefei, Anhui, China Not yet recruiting Xiangpeng Hu, MD Jun Ye, MD Principal Investigator Xiangpeng Hu, MD Principal Investigator
The First Hospital of Lanzhou University | Lanzhou, Gansu, China Recruiting Xiaorong Mao, MD Xiaorong Mao, MD Principal Investigator Liting Zhang, MD Principal Investigator
Guangdong Second Provincial General Hospital | Guangzhou, Guangdong, China Not yet recruiting Ming Xu, MD Ming Xu, MD Principal Investigator Xiaofeng Li, MD Sub-Investigator
Nanfang Hospital of Southern Medical University | Guangzhou, Guangdong, China Not yet recruiting Jinlin Hou, MD Jinlin Hou, MD Principal Investigator
Zhujiang Hospital of Southern Medical University | Guangzhou, Guangdong, China Not yet recruiting Hua Mao, MD Hua Mao, MD Principal Investigator
Xingtai People's Hospital | Xingtai, Hebei, China Not yet recruiting Qingge Zhang, MD Qingge Zhang, MD Principal Investigator Jitao Wang, MD Sub-Investigator
Zhongda Hospital, Medical School, Southeast University | Nanjing, Jiangsu, China Not yet recruiting Ruihua Shi, MD Ruihua Shi, MD Principal Investigator
The Third Hospital of Zhenjiang Affiliated Jiangsu University | Zhenjiang, Jiangsu, China Not yet recruiting Youwen Tan, MD Youwen Tan, MD Principal Investigator
The Sixth People's Hospital of Shenyang | Shenyang, Liaoning, China Not yet recruiting Yiying Song, MD Yiying Song, MD Principal Investigator
Xi'an Gaoxin Hospital | Xi'an, Shanxi, China Not yet recruiting Ying Song, MD Ying Song, MD Principal Investigator Bojiang Zhang, MD Sub-Investigator
Tianjin Second People's Hospital | Tianjin, Tianjin, China Not yet recruiting Jia Li, MD Jia Li, MD Principal Investigator Ping Li, MD Principal Investigator
Zhejiang University Lishui Hospital | Lishui, Zhejiang, China Not yet recruiting Jiansong Ji, MD Jiansong Ji, MD Principal Investigator Zhongwei Zhao, MD Sub-Investigator
King Chulalongkorn Memorial Hospital affiliated to Chulalongkorn University | Bangkok, Thailand Not yet recruiting Sombat Treeprasertsuk, MD Sombat Treeprasertsuk, MD Principal Investigator
Ankara University School of Medicine | Ankara, Turkey Not yet recruiting Necati Örmeci, MD Necati Örmeci, MD Principal Investigator
Standort Länder

China

Thailand

Turkey

Überprüfungsdatum

June 2019

Verantwortliche Partei

Art: Principal Investigator

Ermittlerzugehörigkeit: Nanfang Hospital of Southern Medical University

Vollständiger Name des Ermittlers: Xiaolong Qi

Ermittlertitel: Professor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Armgruppe

Etikette: Overall eligible participants

Beschreibung: Eligible participants will receive standard esophagogastroduodenoscopy and microbiome/peptidome examination.

Patientendaten Undecided
Studiendesign Info

Beobachtungsmodell: Cohort

Zeitperspektive: Prospective

Quelle: ClinicalTrials.gov