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

Primary Purpose

Chronic Liver Disease, Esophageal Varices

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Endoscopy

About this trial

This is an interventional screening trial for Chronic Liver Disease focused on measuring Ammonia, bleeding risk factors, endoscopic risk signs for bleeding, esophageal varices

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Tanta Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Endoscopy

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03212872

First Posted

July 7, 2017

Last Updated

July 7, 2017

Sponsor

Tanta University

1. Study Identification

Unique Protocol Identification Number

NCT03212872

Brief Title

Blood Ammonia as Predictor for Esophageal Varices and Risk of Bleeding

Acronym

Official Title

Evaluation of Blood Ammonia Level as a Non Invasive Predictor for Presence of Gastroesophageal Varices and Risk of Bleeding

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Unknown status

Study Start Date

July 7, 2016 (Actual)

Primary Completion Date

December 31, 2018 (Anticipated)

Study Completion Date

December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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: - 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Liver Disease, Esophageal Varices

Keywords

Ammonia, bleeding risk factors, endoscopic risk signs for bleeding, esophageal varices

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Endoscopy

Arm Type

Other

Intervention Type

Diagnostic Test

Intervention Name(s)

Endoscopy

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ferial El-Kalla, MD

Phone

00201006023289

f.elkalla@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ferial El-Kalla, MD

Organizational Affiliation

Tanta University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tanta Faculty of Medicine

City

Tanta

State/Province

Gharbiah

ZIP/Postal Code

35127

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ferial El-kalla, MD

Phone

002010060232

f.elkalla@gmail.com

First Name & Middle Initial & Last Name & Degree

Loai Mansour, MD

First Name & Middle Initial & Last Name & Degree

Abdelrahman Kobtan, MD

First Name & Middle Initial & Last Name & Degree

Asmaa Elziftawy, MBBCH

12. IPD Sharing Statement

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Blood Ammonia as Predictor for Esophageal Varices and Risk of Bleeding

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