Correlation of Platelets Count With Endoscopic Findings in a Cohort of Egyptian Patients With Liver Cirrhosis

Portal Hypertension Clinical Trial

Official title:

Correlation of Platelets Count With Endoscopic Findings in a Cohort of Egyptian Patients With Liver Cirrhosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02621372
• Other study ID #: non invasive diagnosis of EV
• Status: Recruiting
• Phase: N/A
• First received: November 27, 2015
• Last updated: June 17, 2017
• Start date: January 2015
• Est. completion date: October 2019

Study information

• Verified date: June 2017
• Source: Tanta University
• Contact: Sherief M Abd-Elsalam, lecturer
• Phone: 00201095159522
• Email: sherif_tropical[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Portal hypertension is a common complication of liver cirrhosis that can lead to development of esophageal varices (EV). They are abnormally dilated veins within the wall of the esophagus that lead to haemorrhage (1). Majority of patients with cirrhosis will develop EV at some point, and about third of these patients will have at least one bleeding episode because of rupture of a varix . For this reason, screening endoscopy for detection of the presence of EV should be part of the diagnostic work-up in patients with cirrhosis. This is a very important preventive step for identification of those patients with variceal bleeding risk and furthermore, identification of patients in urgent need for prophylactic treatment.

All guidelines stress on screening endoscopy for early detection of EV in cirrhotic patients with portal hypertension. However this approach is limited by its invasiveness and cost effectiveness issues of screening endoscopy .

Description:

Recent research has focused on the use of noninvasive methods to detect patients with the intention of avoiding endoscopy in low-risk cases . Thrombocytopenia (platelet count < 150,000/μl) is a common complication in patients of chronic liver disease (CLD) . So, the investigators in this research formulated this study to determine whether platelet count can predict the presence of EV or varices which need prophylactic therapy (medium or large size EV) in a cohort of Egyptian patients with liver cirrhosis and can identify patients with the intention of avoiding endoscopy in low-risk cases.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis of cirrhosis based on history, physical examination, laboratory tests, ultrasound scans and liver biopsy in some occasion.

Exclusion Criteria:

• Hepatocellular carcinoma.

• Portal vein thrombosis.

• Parenteral drug addiction.

Related Conditions & MeSH terms

• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension

Intervention

Other:
• platelet count
Correlation of esophageal varices with platelet count

Locations

Country	Name	City	State
Egypt	Tropical medicine dept.-Tanta university hospital	Tanta

Sponsors (2)

Lead Sponsor	Collaborator
Sherief Abd-Elsalam	Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with esophageal varices and have low platelet count		1 year