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Non-invasive Prediction of Esophageal Varices in Liver Cirrhosis: A Multicenter Observational Study

G

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status

Completed

Conditions

Liver Cirrhosis
Esophageal and Gastric Varices

Treatments

Procedure: Endoscopy

Study type

Observational

Funder types

Other

Identifiers

NCT02593799
NIPEV-1

Details and patient eligibility

About

Esophageal variceal bleeding is one of the most lethal complications of liver cirrhosis. In the early stage of liver cirrhosis, the prediction of esophageal varices is very important for guiding the clinical decision making of primary prophylaxis of variceal bleeding.

Full description

Esophageal variceal bleeding is one of the most lethal complications of liver cirrhosis. In the early stage of liver cirrhosis, the prediction of esophageal varices is very important for guiding the clinical decision making of primary prophylaxis of variceal bleeding. The investigators' recent systematic review evaluated the diagnostic accuracy of APRI, AAR, FIB-4, FI, King, Lok, Forns, and FibroIndex scores in predicting the presence of esophageal varices in liver cirrhosis. However, their diagnostic accuracy was low to moderate. Further study is warranted to establish a reliable score to predict the presence of high-risk esophageal varice in liver cirrhosis.

Enrollment

363 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. A diagnosis of liver cirrhosis.
  2. Age and sex are not limited.
  3. Etiology of liver cirrhosis is not limited.
  4. Routine laboratory data.
  5. Upper gastrointestinal endoscopy.

Exclusion criteria

  1. Non-cirrhotic portal hypertension.
  2. Malignancy.
  3. Absent laboratory data.
  4. A previous diagnosis of esophageal varices.
  5. A previous history of variceal bleeding.

Trial design

363 participants in 2 patient groups

Patients with esophageal varices
Description:
Esophageal varices were confirmed by endoscopy. They were divided into "any grade" and "high-risk" varices.
Treatment:
Procedure: Endoscopy
Patients without esophageal varices
Description:
Patients without esophageal varices were divided into patients without "any grade" or "high-risk" varices.
Treatment:
Procedure: Endoscopy

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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