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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Southern Medical University of Nanfang Hospital | Southern Medical University of Nanfang Hospital |
| |
| Tongji Hospital Affiliated to Tongji University | Tongji Hospital Affiliated to Tongji University |
| |
| The Second Affiliated Hospital Of Nanchang University | The Second Affiliated Hospital Of Nanchang University |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esophagogastroduodenoscopies | Other | Each enrolled patient needs to undergo Esophagogastroduodenoscopies and elastography |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of high-risk esophageal varices | Incidence of high-risk esophageal varices | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hemorrhagic events | Incidence of hemorrhagic events | 4 years |
| Incidence of Clinical decompensation events and deaths | Incidence of Clinical decompensation events and deaths |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who come to the center to see a doctor who meet the enrollment criteria and agree to participate in the study
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinjun Chen, PHd | Contact | 8618588531001 | chjj@smu.edu.cn | |
| Haiyu Wang | Contact | 15602203979 | 375612668@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University | Recruiting | Guangzhou | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36356684 | Derived | 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. |
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Take 10ml blood sample for each patient
| 4 years |
| ID | Term |
|---|---|
| D016145 | Endoscopy, Digestive System |
| ID | Term |
|---|---|
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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