Blood Ammonia as Predictor for Esophageal Varices and Risk of Bleeding

Not Applicable

• Conditions: Chronic Liver Disease; Esophageal Varices
• Interventions: Diagnostic Test: Endoscopy

• Registration Number: NCT03212872
• Lead Sponsor: Tanta University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2016-07-07
• Status Verified: 2017-07
• Study First Submitted: 2017-07-07
• Study First Submitted QC: 2017-07-07
• Last Update Submitted: 2017-07-07
• Study First Posted: 2017-07-11
• Last Update Posted: 2017-07-11
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endoscopy	Endoscopy	-

Primary Outcome Measures

Name	Time	Method
level of serum ammonia in patients with risk factors for bleeding from esophageal varices	24 months	estimation of level of serum ammonia in patients with risk factors for bleeding from esophageal varices

Trial Locations

Locations (1)

Tanta Faculty of Medicine; 🇪🇬 Tanta, Gharbiah, Egypt