Chronic Liver DiseaseEVNCT03212872
Blood Ammonia as Predictor for Esophageal Varices and Risk of Bleeding
A study testing Endoscopy in people with Chronic Liver Disease and Esophageal Varices, run by Tanta University at 1 site in Egypt.
Trial summary
Assessment of blood ammonia level as a non-invasive predictor for presence of EV and risk of bleeding Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Liver Disease, Esophageal Varices
- What is being tested?
- Endoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jul 2016to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with chronic liver disease
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta Faculty of Medicine
Tanta, Gharbiah, 35127
Ferial El-kalla, MD, 002010060232, f.elkalla@gmail.com
Loai Mansour, MD
About this study
Official title: Evaluation of Blood Ammonia Level as a Non Invasive Predictor for Presence of Gastroesophageal Varices and Risk of Bleeding
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.
- Conditions
- Chronic Liver Disease, Esophageal Varices
- Being tested
- Endoscopy
- Keywords
- Ammonia, bleeding risk factors, endoscopic risk signs for bleeding, esophageal varices
- Medical subject headings
- Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoscopyDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Endoscopy | Other | Not described Receives: Diagnostic Test: Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start7 Jul 2016
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferial El-Kalla, Tanta University
- Investigators
- Ferial El-Kalla, MD, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212872
- Sponsor's protocol ID
- 30142/03/31
- Acronym
- EV
- Status last verified
- Jul 2017
- First submitted
- 7 Jul 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Blood Ammonia Level as a Non Invasive Predictor for Presence of Gastroesophageal Varices and Risk of Bleeding
- ClinicalTrials.gov ID
- NCT03212872
- Acronym / sponsor ID
- EV / 30142/03/31
- Conditions
- Chronic Liver Disease, Esophageal Varices
- Keywords
- Ammonia, bleeding risk factors, endoscopic risk signs for bleeding, esophageal varices
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 7 Jul 2016 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopy | Other | Diagnostic Test: Endoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with chronic liver disease
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopy | Diagnostic test | Endoscopy |
Primary outcome
level of serum ammonia in patients with risk factors for bleeding from esophageal varices
Time frame: 24 months
estimation of level of serum ammonia in patients with risk factors for bleeding from esophageal varices
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ferial El-Kalla, MD principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopy in people with Chronic Liver Disease and Esophageal Varices, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ferial El-Kalla, MD (00201006023289, f.elkalla@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of serum ammonia in patients with risk factors for bleeding from esophageal varices (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.