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Non-invasive Method for Predicting the Presence of Gastroesophageal Varices in Patients With Cirrhosis-a Prospective, Multicenter Trial

NCT ID: NCT04890730

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

992 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2024-10-30

Brief Summary

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Gastroesophageal varices are a complication of portal hypertension in cirrhosis.Endoscopy is an unsatisfactory screening test.In this prospective clinical study,we will enroll patients with cirrhosis of various causes, all of whom undergo laboratory tests, elastography, and serum proteomic differential protein testing, including liver elastography (LSM) and spleen elastography (SSM). Baveno VI or expanded BavenoVI criteria are validated by comparing patients' LSM and PLT. LSM, SSM, serum differential protein, platelet count, and EGD data to evaluate the clinical value of SSM and differential proteins in excluding cirrhosis with varices. At the same time, a new predictive model of variceal varices will be established to evaluate the diagnostic value of SSM and differential protein for esophagogastric varices, and a non-invasive method for reliably predicting and evaluating cirrhosis with esophageal varices will be found. And each patient will be followed up every 6 months to 1 year, and the outcome event will be recorded.

Detailed Description

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Gastroesophageal varices are a complication of portal hypertension in cirrhosis.Endoscopy is invasive method as an unsatisfactory screening test.In this prospective clinical study, we will enroll patients with cirrhosis of various causes, all of patients whom undergo laboratory tests, elastography, and serum proteomic differential protein testing, including LSM and SSM. Baveno VI or expanded BavenoVI criteria are validated by comparing patients' LSM and PLT. LSM,SSM, serum differential protein, platelet count, and EGD data to evaluate the clinical value of SSM and differential proteins in excluding cirrhosis with varices. At the same time, based on SSM and serum differential protein, a new predictive model of variceal varices will be established to evaluate the diagnostic value of SSM and differential protein for esophagogastric varices, and a non-invasive method for reliably predicting and evaluating cirrhosis with esophageal varices will be found. And each patient will be followed up every 6 months to 1 year, and the outcome event will be recorded.

Conditions

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Gastroesophageal Varices; Decompensation Event

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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The Second Affiliated Hospital Of Nanchang University

The Second Affiliated Hospital Of Nanchang University

Esophagogastroduodenoscopies

Intervention Type OTHER

Each enrolled patient needs to undergo Esophagogastroduodenoscopies and elastography

Southern Medical University of Nanfang Hospital

Southern Medical University of Nanfang Hospital

Esophagogastroduodenoscopies

Intervention Type OTHER

Each enrolled patient needs to undergo Esophagogastroduodenoscopies and elastography

Tongji Hospital Affiliated to Tongji University

Tongji Hospital Affiliated to Tongji University

Esophagogastroduodenoscopies

Intervention Type OTHER

Each enrolled patient needs to undergo Esophagogastroduodenoscopies and elastography

Interventions

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Esophagogastroduodenoscopies

Each enrolled patient needs to undergo Esophagogastroduodenoscopies and elastography

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 1\. The age ranged from 18 to 80 years. 2. Clinical or pathological diagnosis of cirrhosis; 3. Electronic gastroscopy is planned; 4. To agree and sign the informed consent;

Exclusion Criteria

* 1.Orthotopic liver transplantation patients; 2. Patients who have undergone transjugular intrahepatic portosystemic shunt (TIPS),or previous surgical shunt; 3. Pregnant women; 4. Neurological or psychiatric disorders;
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University

Guangzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jinjun Chen, PHd

Role: CONTACT

[email protected]
8618588531001

Haiyu Wang

Role: CONTACT

[email protected]
15602203979

Facility Contacts

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Jinjun Chen, PHD

Role: primary

[email protected]
86-18588531001

References

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Zhang X, Song J, Zhang Y, Wen B, Dai L, Xi R, Wu Q, Li Y, Luo X, Lan X, He Q, Luo W, Lai Q, Ji Y, Zhou L, Qi T, Liu M, Zhou F, Wen W, Li H, Liu Z, Chen Y, Zhu Y, Li J, Huang J, Cheng X, Tu M, Hou J, Wang H, Chen J. Baveno VII algorithm outperformed other models in ruling out high-risk varices in individuals with HBV-related cirrhosis. J Hepatol. 2023 Mar;78(3):574-583. doi: 10.1016/j.jhep.2022.10.030. Epub 2022 Nov 7.

Reference Type DERIVED
PMID: 36356684 (View on PubMed)

Other Identifiers

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NFEC-2020-222

Identifier Type: -

Identifier Source: org_study_id