NCT03212872

Brief Summary

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

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
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

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

July 7, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 7, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

2.5 years

First QC Date

July 7, 2017

Last Update Submit

July 7, 2017

Conditions

Chronic Liver DiseaseEsophageal Varices

Keywords

Ammoniableeding risk factorsendoscopic risk signs for bleedingesophageal varices

Outcome Measures

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

    24 months

Study Arms (1)

Endoscopy

OTHER
Diagnostic Test: Endoscopy

Interventions

EndoscopyDIAGNOSTIC_TEST
Endoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with chronic liver disease

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta Faculty of Medicine

Tanta, Gharbiah, 35127, Egypt

RECRUITING

MeSH Terms

Conditions

Esophageal and Gastric Varices

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesHypertension, PortalLiver Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ferial El-Kalla, MD

    Tanta University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ferial El-Kalla, MD

CONTACT

00201006023289f.elkalla@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 7, 2017

First Posted

July 11, 2017

Study Start

July 7, 2016

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

July 11, 2017

Record last verified: 2017-07

Locations

EG(1)