Blood Ammonia as Predictor for Esophageal Varices and Ris... | NCT03212872

Studies
Blood Ammonia as Predictor for Esophageal Varices and Risk of Bleeding

NCT03212872

Sponsor

Tanta University

Status

Unknown status

Last Update Posted

Jul 11, 2017Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Chronic Liver Disease
Esophageal Varices

Interventions

Endoscopy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 7, 2016Actual

Primary Completion Date

Dec 31, 2018Estimated

Completion Date

Dec 31, 2018Estimated

First Submitted Date

Jul 7, 2017

First Submission Date that Met QC Criteria

Jul 7, 2017

First Posted Date

Jul 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2017

Last Update Posted Date

Jul 11, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ferial El-Kalla, Professor, Tanta UniversityPrincipal Investigator

Lead Sponsor

Tanta UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Label	Type	Description	Intervention Names
Endoscopy	Other		Diagnostic Test: Endoscopy

Name	Type	Description	Arm Group Labels	Other Names
Endoscopy	Diagnostic Test		Endoscopy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ferial El-Kalla, MD	Contact	00201006023289		f.elkalla@gmail.com

Overall Officials

Name	Affiliation	Role
Ferial El-Kalla, MD	Tanta University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tanta Faculty of Medicine	Recruiting	Tanta	Gharbiah	35127	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D004932	Esophageal and Gastric Varices

Ancestor Terms

ID	Term
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D006975	Hypertension, Portal

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004724	Endoscopy

Ancestor Terms

ID	Term
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D019060	Minimally Invasive Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided