Gastric Antral Vascular Ectasia in Patients With Cirrhosis: Risk-factors and Associations.

NCT05690750 | Unknown

• 1 other identifier: ILBS-Cirrhosis-54
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Antral Vascular Ectasia; Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

  3 months

• Grade of esophageal varices among cirrhotic patients with GAVE, compared to cirrhotic patients without GAVE.

  3 months

• Prevalence of proximal gastric vascular ectasias among cirrhotic patients with GAVE.

  3 months

• Comparison of the number of features of metabolic syndrome among cirrhotic patients with GAVE and cirrhotic patients without GAVE.

  3 months

Study Arms (2)

Case

Cirrhosis with GAVE

Other: No intervention

Control

Cirrhosis without GAVE

Other: No intervention

Interventions

No intervention OTHER

No intervention as this is an observational study.

Case; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Gastric Antral Vascular Ectasia; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Angiodysplasia; Vascular Diseases; Cardiovascular Diseases; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dr Vikram Bhatia, DM

CONTACT

01146300000; vikrambhatiadr@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2023
• First Posted: January 19, 2023
• Study Start: January 19, 2023
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: February 2, 2023

Record last verified: 2023-01

Locations

IN (1)