Non-invasive Method for Predicting the Presence of Gastroesophageal Varices in Patients With Cirrhosis

NCT ID: NCT04123509

Last Updated: 2019-10-11

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

UNKNOWN

Total Enrollment

616 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-09

Study Completion Date

2021-01-31

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, SSM, serum differential protein, platelet count, and EGD data to evaluate the clinical value of SSM and differential proteins in excluding cirrhosis of cirrhosis.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.

Detailed Description

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Conditions

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Gastroesophageal Varices Portal Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

1. The age ranged from 18 to 75 years.
2. Clinical or pathological diagnosis of cirrhosis;
3. Electronic gastroscopy is planned;
4. To agree and sign the informed consent;

Exclusion Criteria

1. Hepatocellular carcinoma or other malignant tumors have been or are currently diagnosed;
2. Orthotopic liver transplantation patients;
3. Patients who have undergone transjugular intrahepatic portosystemic shunt (TIPS),or previous surgical shunt;
4. Pregnant women;
5. Neurological or psychiatric disorders;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jinjun Chen, PHD

Role: CONTACT

8618588531001

Biao Wen

Role: CONTACT

8613320961408

Facility Contacts

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Jinjun Chen, PHD

Role: primary

86-18588531001

References

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Sharma S, Agarwal S. Prospective validation of Baveno VI criteria in virally supressed HBV cirrhosis - more evidence is needed. J Hepatol. 2021 Mar;74(3):758-759. doi: 10.1016/j.jhep.2020.10.007. Epub 2021 Jan 19. No abstract available.

Reference Type DERIVED
PMID: 33353741 (View on PubMed)

Wang H, Wen B, Chang X, Wu Q, Wen W, Zhou F, Guo Y, Ji Y, Gu Y, Lai Q, He Q, Li J, Chen J, Hou J. Baveno VI criteria and spleen stiffness measurement rule out high-risk varices in virally suppressed HBV-related cirrhosis. J Hepatol. 2021 Mar;74(3):584-592. doi: 10.1016/j.jhep.2020.09.034. Epub 2020 Oct 8.

Reference Type DERIVED
PMID: 33039403 (View on PubMed)

Other Identifiers

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011

Identifier Type: -

Identifier Source: org_study_id

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