Blood Ammonia as Predictor for Esophageal Varices and Risk of Bleeding

NCT ID: NCT03212872

Last Updated: 2017-07-11

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-07

Study Completion Date

2018-12-31

Brief Summary

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Assessment of blood ammonia level as a non-invasive predictor for presence of EV and risk of bleeding

Detailed Description

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A prospective cross sectional study on 150 consecutive patients screening for esophageal varices.

Patient groups groups:

Group (1): 100 patients with esophageal varices

Group (2): 50 chronic liver disease patients with no esophageal varices as a control group.

All patients will be subjected to:

1. \- Detailed history-taking
2. \- Full clinical examination
3. \- Laboratory investigations:

* Complete blood picture (CBC)
* Erythrocyte sedimentation rate (ESR)
* Renal function tests
* Liver function tests
* Prothrombin time and activity
* Viral markers (HCV Ab - HBV Ag)
* Blood ammonia level.
4. \- Pelviabdominal US: Ultrasound examination of the liver, portal venous system, spleen, kidney and other abdominal organs.
5. \- Upper GITendoscopy:

* Varices will be classified according to the Japanese classification 1996,
* The Baveno 11 score will be used to differentiate between mild and severe portal hypertensive gastropathy.

Conditions

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Chronic Liver Disease Esophageal Varices

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Endoscopy

Group Type OTHER

Endoscopy

Intervention Type DIAGNOSTIC_TEST

Interventions

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Endoscopy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* patients with chronic liver disease

Exclusion Criteria

* Patient in hepatic encephalopathy or coma.
* Patient in active bleeding or with history of bleeding within the two weeks prior to entry in the study .
* Patients with heart failure.
* Patients with renal failure.
* Patient with hepatocellular carcinoma and portal vein thrombosis.
* Patient taking Beta blockers.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Ferial El-Kalla

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ferial El-Kalla, MD

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

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Tanta Faculty of Medicine

Tanta, Gharbiah, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ferial El-Kalla, MD

Role: CONTACT

00201006023289

Facility Contacts

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Ferial El-kalla, MD

Role: primary

002010060232

Other Identifiers

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30142/03/31

Identifier Type: -

Identifier Source: org_study_id

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