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

Study Overview
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Brief Summary
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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
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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.

Conditions
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Platelet Count/Spleen Diameter Ratio, Child-Pugh Classification

Intervention / Treatment
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* Other: Platelet count/spleen diameter ratio


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Esophageal varices haemorrhage group<br>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. | Other: Platelet count/spleen diameter ratio<br>* Platelet count were evaluated by complete blood count, and ultrasound was used to measure the longest diameter of the spleen.The platelet count/spleen diameter ratio was calculated<br>* Other names: PC/SD ratio;|
| no haemorrhage but esophageal varice presence<br>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. | Other: Platelet count/spleen diameter ratio<br>* Platelet count were evaluated by complete blood count, and ultrasound was used to measure the longest diameter of the spleen.The platelet count/spleen diameter ratio was calculated<br>* Other names: PC/SD ratio;|
| no esophageal varice but cirrhotic<br>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 . | Other: Platelet count/spleen diameter ratio<br>* Platelet count were evaluated by complete blood count, and ultrasound was used to measure the longest diameter of the spleen.The platelet count/spleen diameter ratio was calculated<br>* Other names: PC/SD ratio;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet count/spleen diameter ratio | 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 | up to 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child-Pugh score. | 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 | up to 2.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet count/spleen diameter ratio, China