Clinical trial NCT04123509: Non-invasive Method for Predicting the Presence of Gastroesophageal Varices in Patients With Cirrhosis
Official title: Non-invasive Method for Predicting the Presence of Gastroesophageal Varices in Patients With Cirrhosis: a Prospective, Single-center Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastroesophageal Varices
Portal Hypertension
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2019-10-11
Enrollment: 616
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cirrhosis of various etiologies

Brief summary: 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.


Eligibility criteria: 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;

Primary outcomes:
measure: high-risk esophageal varices
timeFrame: 2 years
Secondary outcomes:
measure: bleeding event happen
timeFrame: 1 year
measure: bleeding event happen
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
References:
citation: 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.
citation: 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.