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

NCT ID: NCT02546414

Last Updated: 2015-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-08-31

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Esophageal varices haemorrhage group

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.

Platelet count/spleen diameter ratio

Intervention Type OTHER

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

no haemorrhage but esophageal varice presence

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.

Platelet count/spleen diameter ratio

Intervention Type OTHER

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

no esophageal varice but cirrhotic

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 .

Platelet count/spleen diameter ratio

Intervention Type OTHER

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

Interventions

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Platelet count/spleen diameter ratio

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

Intervention Type OTHER

Other Intervention Names

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PC/SD ratio

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
Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shengliang Chen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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RJLIJINHUI-2015

Identifier Type: -

Identifier Source: org_study_id

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