Gastric Antral Vascular EctasiaNCT05690750
Gastric Antral Vascular Ectasia in Patients With Cirrhosis: Risk-factors and Associations.
An observational study of Gastric Antral Vascular Ectasia and Liver Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
We will evaluate all out-patients and in-patients with cirrhosis, who undergo upper gastrointestinal endoscopy (EGD) in the Department of Hepatology, Institute of Liver and Biliary Sciences (ILBS), for inclusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Antral Vascular Ectasia, Liver Cirrhosis
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- 19 Jan 2023to 30 Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All out-patients and in-patients who undergo upper gastrointestinal endoscopy (EGD) in the Department of Hepatology, Institute of Liver and Biliary Sciences (ILBS), will be evaluated for inclusion. Diagnosis of cirrhosis will be based on a combination of imaging features, liver biopsy, elastography measurements, and signs of portal hypertension.
Who may be able to join
- All patients with cirrhosis, with age >18-years, who have characteristic findings of GAVE on endoscopy.
Who cannot join
- Active upper GI bleeding preventing adequate mucosal evaluation.
- Patients unable or unwilling to give informed consent.
- Endoscopic treatment of GAVE in past one month.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Vikram Bhatia, DM, 01146300000, vikrambhatiadr@gmail.com
About this study
We will evaluate all out-patients and in-patients with cirrhosis, who undergo upper gastrointestinal endoscopy (EGD) in the Department of Hepatology, Institute of Liver and Biliary Sciences (ILBS), for inclusion. Patients with cirrhosis, with age >18-years, who have characteristic findings of GAVE on endoscopy will be included in this study. Their clinical and biochemical features, and endoscopy findings will be compared with a gender and age-matched control group of cirrhosis without GAVE. This observational, case-control study will aim to define the predictors of GAVE in patients with cirrhosis.
Read the detailed description
Primary Objective: To study whether GAVE is more prevalent among patients with cirrhosis who have diabetes mellitus, compared to cirrhotic patients without diabetes.
- Secondary objectives:
- Relationship of etiology of cirrhosis with occurrence of GAVE.
- Relationship of severity of cirrhosis (CTP score and MELD score), with GAVE.
- Features of metabolic syndrome among cirrhotic patients with GAVE.
- Variceal grade and previous endotherapy with occurrence of GAVE among patients with cirrhosis.
- Prevalence of proximal gastric vascular ectasias among cirrhotic patients with GAVE. (b) Methodology:
- Study population: All out-patients and in-patients who undergo upper gastrointestinal endoscopy (EGD) in the Department of Hepatology, Institute of Liver and Biliary Sciences (ILBS), will be evaluated for inclusion. Diagnosis of cirrhosis will be based on a combination of imaging features, liver biopsy, elastography measurements, and signs of portal hypertension. We will include patients with cirrhosis with age >18-years, who have characteristic findings of GAVE on endoscopy in this study.
- Study design: Case-control, observational study.
- Study period: 3-months.
- Sample size with justification: There are three existing studies which have shown an association of diabetes mellitus (DM) with occurrence of GAVE [Fouad M. JGH Open 2021; Smith E. Am J Med 2016; Cleach AL. Canadian Liver Journal 2019]. The prevalence of DM among patients with and without GAVE ranged from 50%-64%, and 24.2% to 29.3%, respectively, in these three studies. Assuming a prevalence of DM of 50% among cirrhosis patients with GAVE, and 25% prevalence of DM among cirrhotic patients without GAVE, we will need 44 cases (and 88 controls) to detect a difference with power of 80% and significance level of 0.05, using the test of independent proportions. We plan to include 50 cases and 100 controls in this study.
- Intervention: None.
- Monitoring and assessment: Not applicable.
- Statistical Analysis: Patients with GAVE will be matched in a 1:2 ratio to controls without GAVE, based on age (±5 years), gender, and timing of diagnostic EGD (±1 year). Comparisons will be performed using Chi-square tests or Fisher exact tests for categorical variables, and t tests, Wilcoxon rank-sum tests or signed rank tests for continuous variables as appropriate. Univariate and multivariate, case and control matched conditional logistic regression models will be utilized to evaluate potential associations between specific risk factors and the diagnosis of GAVE. A p≤0.05 decision rule is established a priori as the null hypothesis rejection rule for all comparisons.
- Adverse effects: No intervention planned, hence no adverse effects anticipated.
- Stopping rule of study: Not applicable. (c) Expected outcome of the project: Elucidation of the predictors of GAVE in patients with cirrhosis.
- Conditions
- Gastric Antral Vascular Ectasia, Liver Cirrhosis
- Being tested
- No intervention
- Medical subject headings
- Gastric Antral Vascular Ectasia, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention as this is an observational study.
| Study group | Role | What they receive |
|---|---|---|
| Case | Cirrhosis with GAVE Receives: Other: No intervention | |
| Control | Cirrhosis without GAVE Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of gastric antral vascular ectasia (GAVE) among cirrhotic patients with diabetes mellitus (fasting blood sugar>126mg/dL, and/or HbA1c >6.5%), compared to cirrhotic patients without diabetes.
Measured: 3 months
Secondary outcomes (5)
Comparison of Model for End-Stage Liver Disease (MELD) scores (on a scale of 6-40) of cirrhotic patients with GAVE and cirrhotic patients without GAVE.
Measured: 3 months
Comparison of Child Turcotte Pugh (CTP) scores (on a scale of 5-15) of cirrhotic patients with GAVE and cirrhotic patients without GAVE.
Measured: 3 months
Grade of esophageal varices among cirrhotic patients with GAVE, compared to cirrhotic patients without GAVE.
Measured: 3 months
Prevalence of proximal gastric vascular ectasias among cirrhotic patients with GAVE.
Measured: 3 months
Comparison of the number of features of metabolic syndrome among cirrhotic patients with GAVE and cirrhotic patients without GAVE.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start19 Jan 2023
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Antral Vascular EctasiaStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690750
- Sponsor's protocol ID
- ILBS-Cirrhosis-54
- Status last verified
- Jan 2023
- First submitted
- 2 Jan 2023
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Antral Vascular Ectasia in Patients With Cirrhosis: Risk-factors and Associations.
- ClinicalTrials.gov ID
- NCT05690750
- Acronym / sponsor ID
- ILBS-Cirrhosis-54
- Conditions
- Gastric Antral Vascular Ectasia, Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 19 Jan 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.
We will evaluate all out-patients and in-patients with cirrhosis, who undergo upper gastrointestinal endoscopy (EGD) in the Department of Hepatology, Institute of Liver and Biliary Sciences (ILBS), for inclusion. Patients with cirrhosis, with age >18-years, who have characteristic findings of GAVE on endoscopy will be included in this study. Their clinical and biochemical features, and endoscopy findings will be compared with a gender and age-matched control group of cirrhosis without GAVE. This observational, case-control study will aim to define the predictors of GAVE in patients with cirrhosis.
Detailed description
Primary Objective: To study whether GAVE is more prevalent among patients with cirrhosis who have diabetes mellitus, compared to cirrhotic patients without diabetes.
- Secondary objectives:
- Relationship of etiology of cirrhosis with occurrence of GAVE.
- Relationship of severity of cirrhosis (CTP score and MELD score), with GAVE.
- Features of metabolic syndrome among cirrhotic patients with GAVE.
- Variceal grade and previous endotherapy with occurrence of GAVE among patients with cirrhosis.
- Prevalence of proximal gastric vascular ectasias among cirrhotic patients with GAVE. (b) Methodology:
- Study population: All out-patients and in-patients who undergo upper gastrointestinal endoscopy (EGD) in the Department of Hepatology, Institute of Liver and Biliary Sciences (ILBS), will be evaluated for inclusion. Diagnosis of cirrhosis will be based on a combination of imaging features, liver biopsy, elastography measurements, and signs of portal hypertension. We will include patients with cirrhosis with age >18-years, who have characteristic findings of GAVE on endoscopy in this study.
- Study design: Case-control, observational study.
- Study period: 3-months.
- Sample size with justification: There are three existing studies which have shown an association of diabetes mellitus (DM) with occurrence of GAVE [Fouad M. JGH Open 2021; Smith E. Am J Med 2016; Cleach AL. Canadian Liver Journal 2019]. The prevalence of DM among patients with and without GAVE ranged from 50%-64%, and 24.2% to 29.3%, respectively, in these three studies. Assuming a prevalence of DM of 50% among cirrhosis patients with GAVE, and 25% prevalence of DM among cirrhotic patients without GAVE, we will need 44 cases (and 88 controls) to detect a difference with power of 80% and significance level of 0.05, using the test of independent proportions. We plan to include 50 cases and 100 controls in this study.
- Intervention: None.
- Monitoring and assessment: Not applicable.
- Statistical Analysis: Patients with GAVE will be matched in a 1:2 ratio to controls without GAVE, based on age (±5 years), gender, and timing of diagnostic EGD (±1 year). Comparisons will be performed using Chi-square tests or Fisher exact tests for categorical variables, and t tests, Wilcoxon rank-sum tests or signed rank tests for continuous variables as appropriate. Univariate and multivariate, case and control matched conditional logistic regression models will be utilized to evaluate potential associations between specific risk factors and the diagnosis of GAVE. A p≤0.05 decision rule is established a priori as the null hypothesis rejection rule for all comparisons.
- Adverse effects: No intervention planned, hence no adverse effects anticipated.
- Stopping rule of study: Not applicable. (c) Expected outcome of the project: Elucidation of the predictors of GAVE in patients with cirrhosis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: No interventionCirrhosis with GAVE |
| Control | – | Other: No interventionCirrhosis without GAVE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All out-patients and in-patients who undergo upper gastrointestinal endoscopy (EGD) in the Department of Hepatology, Institute of Liver and Biliary Sciences (ILBS), will be evaluated for inclusion. Diagnosis of cirrhosis will be based on a combination of imaging features, liver biopsy, elastography measurements, and signs of portal hypertension.
Key inclusion criteria (1 listed)
- All patients with cirrhosis, with age >18-years, who have characteristic findings of GAVE on endoscopy.
Key exclusion criteria (3 listed)
- Active upper GI bleeding preventing adequate mucosal evaluation.
- Patients unable or unwilling to give informed consent.
- Endoscopic treatment of GAVE in past one month.
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 |
|---|---|---|
| No interventionNo intervention as this is an observational study. | Other | Case, Control |
Primary outcome
Prevalence of gastric antral vascular ectasia (GAVE) among cirrhotic patients with diabetes mellitus (fasting blood sugar>126mg/dL, and/or HbA1c >6.5%), compared to cirrhotic patients without diabetes.
Time frame: 3 months
5 secondary outcomes
Comparison of Model for End-Stage Liver Disease (MELD) scores (on a scale of 6-40) of cirrhotic patients with GAVE and cirrhotic patients without GAVE.
Time frame: 3 months
Comparison of Child Turcotte Pugh (CTP) scores (on a scale of 5-15) of cirrhotic patients with GAVE and cirrhotic patients without GAVE.
Time frame: 3 months
Grade of esophageal varices among cirrhotic patients with GAVE, compared to cirrhotic patients without GAVE.
Time frame: 3 months
Prevalence of proximal gastric vascular ectasias among cirrhotic patients with GAVE.
Time frame: 3 months
Comparison of the number of features of metabolic syndrome among cirrhotic patients with GAVE and cirrhotic patients without GAVE.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 Gastric Antral Vascular Ectasia and Liver Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 3 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 2 Feb 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 India. 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 Dr Vikram Bhatia, DM (01146300000, vikrambhatiadr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of gastric antral vascular ectasia (GAVE) among cirrhotic patients with diabetes mellitus (fasting blood sugar>126mg/dL, and/or HbA1c >6.5%), compared to cirrhotic patients without diabetes. (time frame: 3 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 2 Feb 2023.