Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-27 @ 2:14 AM
Study NCT ID:
NCT05690750
Status:
UNKNOWN
Last Update Posted:
2023-02-02
First Post:
2023-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastric Antral Vascular Ectasia in Patients With Cirrhosis: Risk-factors and Associations.
Sponsor:
Institute of Liver and Biliary Sciences, India
Organization:
Study Overview
Official Title:
Gastric Antral Vascular Ectasia in Patients With Cirrhosis: Risk-factors and Associations.
Status:
UNKNOWN
Status Verified Date:
2023-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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:
1. Relationship of etiology of cirrhosis with occurrence of GAVE.
2. Relationship of severity of cirrhosis (CTP score and MELD score), with GAVE.
3. Features of metabolic syndrome among cirrhotic patients with GAVE.
4. Variceal grade and previous endotherapy with occurrence of GAVE among patients with cirrhosis.
5. 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.
\- Secondary objectives:
1. Relationship of etiology of cirrhosis with occurrence of GAVE.
2. Relationship of severity of cirrhosis (CTP score and MELD score), with GAVE.
3. Features of metabolic syndrome among cirrhotic patients with GAVE.
4. Variceal grade and previous endotherapy with occurrence of GAVE among patients with cirrhosis.
5. 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: