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Platelet Count(PC)/Spleen Diameter(SD) Ratio to Predict the Variceal Haemorrhage in HBV Cirrhotic Patients in China

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Completed

Conditions

Platelet Count/Spleen Diameter Ratio
Child-Pugh Classification

Treatments

Other: Platelet count/spleen diameter ratio

Study type

Observational

Funder types

Other

Identifiers

NCT02546414
RJLIJINHUI-2015

Details and patient eligibility

About

To validate the PC/SD ratio to be used to predict the variceal haemorrhage in Chinese patients with hepatitis B virus (HBV)-associated hepatic cirrhosis.

Full description

Esophageal variceal bleeding remains the leading cause of acute mortality in patients with cirrhosis. Using noninvasive parameters for high-risk variceal haemorrhage may reduce the need for endoscopies. The ratio of platelet count/diameter of the spleen (PC/SD ratio) is the principal noninvasive predictor of esophageal varices. This was an analytical cross-sectional study to validate the diagnostic test for HBV hepatic cirrhosis and was performed between January 2013 and August 2015. This study is to validate the PC/SD ratio to identification of those patients with high bleeding risk and selection for prophylactic treatment.

Enrollment

150 patients

Sex

All

Ages

45 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with a diagnosis of HBV hepatic cirrhosis

Exclusion criteria

  • Patients with hepatocellular carcinoma,
  • use of medications for the primary prophylaxis of variceal bleeding,
  • history of esophageal variceal bleeding,
  • alcohol consumption within the admission and a history of ligation,
  • sclerotherapy, and/or
  • portal hypertension surgery

Trial design

150 participants in 3 patient groups

Esophageal varices haemorrhage group
Description:
HBV hepatic cirrhosis with first esophageal varices haemorrhage were included and stratified using their Child-Pugh score. The platelet count were evaluated, and ultrasound was used to measure the longest diameter of the spleen. The platelet count(PC)/spleen diameter (SD)ratio was calculated and analyzed to determine whether it can predict the variceal haemorrhage. Upper gastrointestinal endoscopy was used as the gold standard.
Treatment:
Other: Platelet count/spleen diameter ratio
no haemorrhage but esophageal varice presence
Description:
HBV hepatic cirrhosis with no esophageal varices haemorrhage were included and upper gastrointestinal endoscopy were validate.They also stratified using their Child-Pugh score. The platelet count and longest diameter of the spleen were evaluated, The PC/SD ratio was calculated and analyzed to determine whether it can predict the variceal presence.
Treatment:
Other: Platelet count/spleen diameter ratio
no esophageal varice but cirrhotic
Description:
HBV hepatic cirrhosis with no esophageal varices were included and also validated by upper gastrointestinal endoscopy.They stratified using their Child-Pugh score. The platelet count and longest diameter of the spleen were evaluated,The PC/SD was calculated and analyzed to determine whether it can predict the variceal absence .
Treatment:
Other: Platelet count/spleen diameter ratio

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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