Clinical trial NCT05690750: Gastric Antral Vascular Ectasia in Patients With Cirrhosis: Risk-factors and Associations.
Official title: Gastric Antral Vascular Ectasia in Patients With Cirrhosis: Risk-factors and Associations.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Antral Vascular Ectasia
Liver Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: Inclusion Criteria:

- All patients with cirrhosis, with age \>18-years, who have characteristic findings of GAVE on endoscopy.

Exclusion Criteria:

1. Active upper GI bleeding preventing adequate mucosal evaluation.
2. Patients unable or unwilling to give informed consent.
3. Endoscopic treatment of GAVE in past one month.

Primary outcomes:
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.
timeFrame: 3 months
Secondary outcomes:
measure: 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.
timeFrame: 3 months
measure: Comparison of Child Turcotte Pugh (CTP) scores (on a scale of 5-15) of cirrhotic patients with GAVE and cirrhotic patients without GAVE.
timeFrame: 3 months
measure: Grade of esophageal varices among cirrhotic patients with GAVE, compared to cirrhotic patients without GAVE.
timeFrame: 3 months
measure: Prevalence of proximal gastric vascular ectasias among cirrhotic patients with GAVE.
timeFrame: 3 months
measure: Comparison of the number of features of metabolic syndrome among cirrhotic patients with GAVE and cirrhotic patients without GAVE.
timeFrame: 3 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
References: