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

Completed

• Conditions: Child-Pugh Classification; Platelet Count/Spleen Diameter Ratio
• Interventions: Other: Platelet count/spleen diameter ratio

• Registration Number: NCT02546414
• Lead Sponsor: RenJi Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2015-07
• Study Completion: 2015-08
• Study First Submitted: 2015-08-26
• Status Verified: 2015-09
• Study First Submitted QC: 2015-09-08
• Last Update Submitted: 2015-09-08
• Study First Posted: 2015-09-10
• Last Update Posted: 2015-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Esophageal varices haemorrhage group	Platelet count/spleen diameter ratio	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.
no haemorrhage but esophageal varice presence	Platelet count/spleen diameter ratio	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.
no esophageal varice but cirrhotic	Platelet count/spleen diameter ratio	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 .

Primary Outcome Measures

Name	Time	Method
Platelet count/spleen diameter ratio	up to 2.5 years	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

Secondary Outcome Measures

Name	Time	Method
Child-Pugh score.	up to 2.5 years	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

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, Shanghai, China