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Blood Ammonia as Predictor for Esophageal Varices and Risk of Bleeding (EV)

T

Tanta University

Status

Unknown

Conditions

Esophageal Varices
Chronic Liver Disease

Treatments

Diagnostic Test: Endoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT03212872
30142/03/31

Details and patient eligibility

About

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

Full 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:

    • Detailed history-taking
    • Full clinical examination
    • 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.
    • Pelviabdominal US: Ultrasound examination of the liver, portal venous system, spleen, kidney and other abdominal organs.
    • 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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

150 participants in 1 patient group

Endoscopy
Other group
Treatment:
Diagnostic Test: Endoscopy

Trial contacts and locations

1

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Central trial contact

Ferial El-Kalla, MD

Data sourced from clinicaltrials.gov

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