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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03212872
Other study ID # 30142/03/31
Secondary ID
Status Recruiting
Phase N/A
First received July 7, 2017
Last updated July 7, 2017
Start date July 7, 2016
Est. completion date December 31, 2018

Study information

Verified date July 2017
Source Tanta University
Contact Ferial El-Kalla, MD
Phone 00201006023289
Email f.elkalla@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Diagnostic Test:
Endoscopy


Locations

Country Name City State
Egypt Tanta Faculty of Medicine Tanta Gharbiah

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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