Portal HypertensionNCT02621372
Correlation of Platelets Count With Endoscopic Findings in a Cohort of Egyptian Patients With Liver Cirrhosis
An observational study of Portal Hypertension, run by Sherief Abd-Elsalam at 1 site in Egypt.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Portal Hypertension
- What is being tested?
- platelet count
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2015to Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A total of 110 cirrhotic patients were included
Who may be able to join
- Diagnosis of cirrhosis based on history, physical examination, laboratory tests, ultrasound scans and liver biopsy in some occasion.
Who cannot join
- Hepatocellular carcinoma.
- Portal vein thrombosis.
- Parenteral drug addiction.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tropical medicine dept.-Tanta university hospital
Tanta
Sherief Abd-Elsalam, Sherif_tropical@yahoo.com
About this study
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 .
Read the 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.
- Conditions
- Portal Hypertension
- Being tested
- platelet count
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet countOther
Correlation of esophageal varices with platelet count
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with esophageal varices and have low platelet count
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startJan 2015
- Primary completionSep 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherief Abd-Elsalam
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Sponsor-investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Sherief Abd-Elsalam, Principal investigator, Tanta university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621372
- Sponsor's protocol ID
- non invasive diagnosis of EV
- Status last verified
- Jun 2017
- First submitted
- 27 Nov 2015
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Platelets Count With Endoscopic Findings in a Cohort of Egyptian Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT02621372
- Acronym / sponsor ID
- non invasive diagnosis of EV
- Conditions
- Portal Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- Jan 2015 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 3 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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 design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 110 cirrhotic patients were included
Key inclusion criteria (1 listed)
- Diagnosis of cirrhosis based on history, physical examination, laboratory tests, ultrasound scans and liver biopsy in some occasion.
Key exclusion criteria (3 listed)
- Hepatocellular carcinoma.
- Portal vein thrombosis.
- Parenteral drug addiction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| platelet countCorrelation of esophageal varices with platelet count | Other | – |
Primary outcome
Number of patients with esophageal varices and have low platelet count
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Individual participant dataSharing planned: Undecided
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Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherief Abd-Elsalam principal investigator
Tanta university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Portal Hypertension, run by Sherief Abd-Elsalam at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherief M Abd-Elsalam, lecturer (00201095159522, sherif_tropical@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with esophageal varices and have low platelet count (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2017.