NCT02621372

Brief 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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

4.7 years

First QC Date

November 27, 2015

Last Update Submit

June 17, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of patients with esophageal varices and have low platelet count

    1 year

Interventions

Correlation of esophageal varices with platelet count

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A total of 110 cirrhotic patients were included

You may qualify if:

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

You may not qualify if:

  • Hepatocellular carcinoma.
  • Portal vein thrombosis.
  • Parenteral drug addiction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tropical medicine dept.-Tanta university hospital

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Hypertension, Portal

Interventions

Platelet Count

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Blood Cell CountCell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsPlatelet Function TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Sherief Abd-Elsalam

    Tanta university hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherief M Abd-Elsalam, lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Hepatology and gastroenterology dept., tanta university, M.D., Principle investigator

Study Record Dates

First Submitted

November 27, 2015

First Posted

December 3, 2015

Study Start

January 1, 2015

Primary Completion

September 1, 2019

Study Completion

October 1, 2019

Last Updated

June 20, 2017

Record last verified: 2017-06

Locations