Esophageal VaricesNCT05781828
Noninvasive Methods For Prediction of Esophageal Varices in Children
An observational study of Esophageal Varices, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this study is to use non-invasive methods to identify patients at risk of developing gastrointestinal varices and correlation of these non-invasive methods with the degree of esophageal varices and the presence or absence of risk signs of bleeding such as cherry red spots. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Esophageal Varices
- What is being tested?
- Detailed abdominal ultrasound
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2023to 1 Sep 2023
- Phase
- Observational
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients aged < 18 years with a diagnosis of chronic liver disease, extra hepatic portal vein obstruction and/ or liver cirrhosis.
Who may be able to join
- patients aged < 18 years with a diagnosis of chronic liver disease, extra hepatic portal vein obstruction and/ or liver cirrhosis.
Who cannot join
- patient who underwent prior variceal treatment (any type) or variceal bleeding prophylaxis (including nonselective β-blocker use, endoscopic variceal ligation or sclerotherapy, surgical portosystemic shunt or transjugular intrahepatic portosystemic shunt insertion), liver transplantation, and malignancy.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to use non-invasive methods to identify patients at risk of developing gastrointestinal varices and correlation of these non-invasive methods with the degree of esophageal varices and the presence or absence of risk signs of bleeding such as cherry red spots.
Read the detailed description
Portal hypertension is the underlying pathophysiological process that leads to the formation of portosystemic collaterals and heralds the onset of a severe complication: variceal hemorrhage. It is estimated that approximately 50% of pediatric patients with chronic liver disease and 90% of those with extrahepatic portal vein obstruction (EHPVO) will experience gastrointestinal bleeding.
Esophagogastroduodenoscopy (EGD) is considered the primary modality for detection and surveillance of esophageal varices (EV) and to determine the risk of bleeding. Varices were graded into four grades I, II, III, and IV according to the Modified Paquet classification. however, invasiveness of the technique and a significant risk associated with sedation on long-term neurological outcomes have limited its use.
Many studies have sought to determine clinical, laboratory, or other noninvasive methods that could predict the presence of EV. Preliminary data suggests that laboratory tests such as platelet count, albumin and ultrasonographic parameters such as presence of splenomegaly, spleen size z score and platelet count to spleen size ratio and the clinical prediction rule (CPR; calculated from platelet count, spleen size z-score, and albumin concentration) may be useful as first-line tools for identification of adults and pediatric patients at risk of variceal development and thus reduce the number of unnecessary EGDs.
- Conditions
- Esophageal Varices
- Being tested
- Detailed abdominal ultrasound
- 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.
Detailed abdominal ultrasoundDiagnostic test
size of the liver and architecture, size of the spleen, presence or absence of ascites
| Study group | Role | What they receive |
|---|---|---|
| Laboratory investigation | Complete blood count, liver function tests, prothrombin time(PT), prothrombin concentration(PC), international normalized ratio (INR), renal chemistry and electrolytes Receives: Diagnostic Test: Detailed abdominal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
noninvasive methods for prediction of esophageal varices in children compared to esophagogastroduodenoscopy results
use non-invasive methods to identify patients at risk of developing gastrointestinal varices and correlation of these non-invasive methods with the degree of esophageal varices and the presence or absence of risk signs of bleeding such as cherry red spots.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start15 Mar 2023
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal VaricesStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Mahmoud Farag, Assiut University
- Investigators
- Emad El-Deen Mahmoud Hammad, Professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781828
- Sponsor's protocol ID
- Esophageal Varices in Children
- Status last verified
- Jul 2023
- First submitted
- 12 Mar 2023
- Last updated
- 18 Jul 2023
- 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 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Methods For Prediction of Esophageal Varices in Children
- ClinicalTrials.gov ID
- NCT05781828
- Acronym / sponsor ID
- Esophageal Varices in Children
- Conditions
- Esophageal Varices
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 23 Mar 2023 (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.
The aim of this study is to use non-invasive methods to identify patients at risk of developing gastrointestinal varices and correlation of these non-invasive methods with the degree of esophageal varices and the presence or absence of risk signs of bleeding such as cherry red spots.
Detailed description
Portal hypertension is the underlying pathophysiological process that leads to the formation of portosystemic collaterals and heralds the onset of a severe complication: variceal hemorrhage. It is estimated that approximately 50% of pediatric patients with chronic liver disease and 90% of those with extrahepatic portal vein obstruction (EHPVO) will experience gastrointestinal bleeding.
Esophagogastroduodenoscopy (EGD) is considered the primary modality for detection and surveillance of esophageal varices (EV) and to determine the risk of bleeding. Varices were graded into four grades I, II, III, and IV according to the Modified Paquet classification. however, invasiveness of the technique and a significant risk associated with sedation on long-term neurological outcomes have limited its use.
Many studies have sought to determine clinical, laboratory, or other noninvasive methods that could predict the presence of EV. Preliminary data suggests that laboratory tests such as platelet count, albumin and ultrasonographic parameters such as presence of splenomegaly, spleen size z score and platelet count to spleen size ratio and the clinical prediction rule (CPR; calculated from platelet count, spleen size z-score, and albumin concentration) may be useful as first-line tools for identification of adults and pediatric patients at risk of variceal development and thus reduce the number of unnecessary EGDs.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laboratory investigation | – | Diagnostic Test: Detailed abdominal ultrasoundComplete blood count, liver function tests, prothrombin time(PT), prothrombin concentration(PC), international normalized ratio (INR), renal chemistry and electrolytes |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients aged < 18 years with a diagnosis of chronic liver disease, extra hepatic portal vein obstruction and/ or liver cirrhosis.
Key inclusion criteria (1 listed)
- patients aged < 18 years with a diagnosis of chronic liver disease, extra hepatic portal vein obstruction and/ or liver cirrhosis.
Key exclusion criteria (1 listed)
- patient who underwent prior variceal treatment (any type) or variceal bleeding prophylaxis (including nonselective β-blocker use, endoscopic variceal ligation or sclerotherapy, surgical portosystemic shunt or transjugular intrahepatic portosystemic shunt insertion), liver transplantation, and malignancy.
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 |
|---|---|---|
| Detailed abdominal ultrasoundsize of the liver and architecture, size of the spleen, presence or absence of ascites | Diagnostic test | Laboratory investigation |
Primary outcome
noninvasive methods for prediction of esophageal varices in children compared to esophagogastroduodenoscopy results
Time frame: baseline
use non-invasive methods to identify patients at risk of developing gastrointestinal varices and correlation of these non-invasive methods with the degree of esophageal varices and the presence or absence of risk signs of bleeding such as cherry red spots.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
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Not yet recruitingObservational study
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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.
Emad El-Deen Mahmoud Hammad, Professor study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Varices, run by Assiut 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 1 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 18 Jul 2023. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
noninvasive methods for prediction of esophageal varices in children compared to esophagogastroduodenoscopy results (time frame: baseline). 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 18 Jul 2023.