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

NCT05875636 | Completed DMC

• 1 other identifier: Pro00129059
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Content Aspiration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of pulmonary aspiration event

  From the time surgery begins until the end of scheduled surgery, assessed up to 24 hours

Study Arms (2)

Patients taking a GLP-1 agonist medication

Participants meeting all inclusion/exclusion criteria who are taking a GLP-1 agonist medication

Other: Esophagogastroduodenoscopy

Controls

Participants meeting all inclusion/exclusion criteria and are NOT taking a GLP-1 agonist medication.

Other: Esophagogastroduodenoscopy

Interventions

Esophagogastroduodenoscopy OTHER

All patients will undergo an esophagogastroduodenoscopy per standard of care, as scheduled.

Controls; Patients taking a GLP-1 agonist medication

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

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29424, United States

Location

MeSH Terms

Conditions

Respiratory Aspiration of Gastric Contents

Interventions

Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Laryngopharyngeal Reflux; Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Respiratory Aspiration; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Phillip R Wilson, M.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator/ Assistant Professor

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 25, 2023
• Study Start: August 21, 2023
• Primary Completion: August 23, 2024
• Study Completion: August 23, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)