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Status unknownNCT03212872EVUpdated Jul 11, 2017

Blood Ammonia as Predictor for Esophageal Varices and Risk of Bleeding

An interventional study of Endoscopy in Chronic Liver Disease and Esophageal Varices, sponsored by Tanta University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-11.

Sponsored by Tanta University · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jul 2016, registered Jul 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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:

    • 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.
02

Conditions studied

  • Chronic Liver Disease
  • Esophageal Varices

Keywords

  • Ammonia
  • bleeding risk factors
  • endoscopic risk signs for bleeding
  • esophageal varices
03

In context

Liver Diseases

2,080 studies on the registry are indexed under Liver Diseases; 389 are open to participants now.

This study's planned enrollment of 150 is above the median of 50 across 1,322 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients with chronic liver disease

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Other
    Endoscopy

    Diagnostic Test: Endoscopy

Interventions

  • Diagnostic testEndoscopy
06

What researchers measure

Primary outcomes

  1. level of serum ammonia in patients with risk factors for bleeding from esophageal varices

    estimation of level of serum ammonia in patients with risk factors for bleeding from esophageal varices

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
  • Tanta Faculty of Medicine
    Tanta, Gharbiah 35127, Egypt
    • Ferial El-kalla, MD · Contact · f.elkalla@gmail.com · 002010060232
    • Loai Mansour, MD · Sub investigator
    • Abdelrahman Kobtan, MD · Sub investigator
    • Asmaa Elziftawy, MBBCH · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03212872
Lead sponsor
Tanta University
Responsible party
Ferial El-Kalla (Professor, Tanta University) — Principal investigator
First posted
Jul 11, 2017
Start date
Jul 7, 2016
Primary completion
Dec 31, 2018 (estimated)
Completion
Dec 31, 2018 (estimated)
Last update
Jul 11, 2017

Study contacts

Ferial El-Kalla, MD
Contact
f.elkalla@gmail.com
00201006023289
Ferial El-Kalla, MD
principal investigator · Tanta University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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