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

June 17, 2017 updated by: Sherief Abd-Elsalam

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 .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

A total of 110 cirrhotic patients were included

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with esophageal varices and have low platelet count
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sherief Abd-Elsalam

Collaborators

Tanta University

Investigators

  • Principal Investigator: Sherief Abd-Elsalam, Tanta University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

November 27, 2015

First Submitted That Met QC Criteria

December 1, 2015

First Posted (Estimate)

December 3, 2015

Study Record Updates

Last Update Posted (Actual)

June 20, 2017

Last Update Submitted That Met QC Criteria

June 17, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • non invasive diagnosis of EV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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