GLP-1 Receptor Agonist Use and Incidence of Retained Gastric Food on Endoscopy

This study will enroll patients ages 18 and over who are in one of the following groups 1) taking a GLP-1 receptor agonist medication 2) not taking a GLP-1 receptor agonist (control group), are undergoing EGS and have appropriately fasted. Study data will be collected in the form of qualitatively observing whether the stomach is empty as expected, or contains solid or clinically relevant liquid contents.

Study Overview

• Status: Recruiting
• Conditions: Gastric Content Aspiration
• Intervention / Treatment: Other: Esophagogastroduodenoscopy

• Study Type: Observational
• Enrollment (Estimated): 260

Contacts and Locations

• Study Contact: Name: Haley Nitchie, MHA; Phone Number: 843-792-1869; Email: nitchie@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29424
      • Recruiting
      • Medical University of South Carolina
      • Contact: Haley Nitchie, MHA; Phone Number: 843-792-1869; Email: nitchie@musc.edu
      • Principal Investigator: Phillip R Wilson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will consist of patients who have appropriately fasted, and are scheduled for an esophagogastroduodenoscopy (EGD). Patients will fall in to two groups: 1) taking a GLP-1 receptor agonist or 2) not taking a receptor agonist medication.

Description

Inclusion Criteria

• Adults 18 years of age and older presenting for esophagogastroduodenoscopy (EGD)

• One of the following groups:

  • GLP-1 receptor agonist cohort: active treatment with any GLP-1 receptor agonist therapy within prior 30 days
  • Control cohort: not taking a GLP-1 receptor agonist medication
• Appropriately fasted per ASA Fasting Guidelines

Exclusion Criteria

• Simultaneous bowel preparation/planned dual endoscopy with colonoscopy
• Any pre-planned alteration to standard fasting guidelines (ASA NPO guidelines)
• Emergency endoscopic procedure
• Concern for active GI bleeding
• Food impaction/foreign body as indication for procedure
• Gastric outlet obstruction/bowel obstruction
• Achalasia
• Zenker's diverticulum
• History of esophageal or gastric surgery
• Active pregnancy
• Chronic daily opioid therapy ≥ 15 MMEs per day
• Prokinetic agent use (i.e. metoclopramide)
• Inability or unwillingness of subject to give informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients taking a GLP-1 agonist medication; Participants meeting all inclusion/exclusion criteria who are taking a GLP-1 agonist medication	Other: Esophagogastroduodenoscopy; All patients will undergo an esophagogastroduodenoscopy per standard of care, as scheduled.
Controls; Participants meeting all inclusion/exclusion criteria and are NOT taking a GLP-1 agonist medication.	Other: Esophagogastroduodenoscopy; All patients will undergo an esophagogastroduodenoscopy per standard of care, as scheduled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retained gastric food	Incidence of clinically significant retained gastric food, defined as visible solid/particulate matter, or liquid volume > 1.5cc/kg	From time of enrollment until the end of surgery, assessed up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of pulmonary aspiration event	From the time surgery begins until the end of scheduled surgery, assessed up to 24 hours

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Phillip R Wilson, M.D., Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2023
• Primary Completion (Estimated): September 15, 2024
• Study Completion (Estimated): September 15, 2024

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Laryngopharyngeal Reflux; Respiratory Aspiration; Respiratory Aspiration of Gastric Contents
• Other Study ID Numbers: Pro00129059

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No