Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy

Randomized Trial of Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy

To assess whether holding incretin-based therapy before endoscopy reduces the likelihood of clinically relevant Residual Gastric Volume (RGV).

Primary Outcomes:

• Residual gastric volume that precludes adequate endoscopic examination
• Residual gastric volume that necessitates premature termination of the endoscopy procedure
• Need for endotracheal intubation due to stomach contents.
• Occurrence of aspiration events requiring extended observation/monitoring, unplanned therapeutics, and/or hospital admission

Secondary Outcomes:

• Presence of any solid food
• Presence of moderate liquid content
• Increased RGV(Residual Gastric Volume) defined as any amount of solid content or > 0.8 mL/Kg of fluid content (measured from the aspiration/suction canister).
• Differences in primary and secondary outcomes between different medications

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes Mellitus, Type 2; Gastroparesis
• Intervention / Treatment: Drug: GLP-1 medication

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Weston, Florida, United States, 33331
      • Cleveland Clinic
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients using incretin-based therapies at a stable dose for more than 1 month.
• Patients scheduled for outpatient esophagogastroduodenoscopy (EGD), endoscopic ultrasound (EUS), or endoscopic retrograde cholangiopancreatography (ERCP) under monitored anesthesia care.

Exclusion Criteria:

• Documented history of gastroparesis (based on a 4-hour solid-phase gastric emptying study)
• Known history of achalasia
• Surgical or genetically altered foregut anatomy
• Known gastric outlet obstruction or pre-procedure imaging suggestive of gastric outlet obstruction.
• Patients who did not follow the standard NPO (nil per oral) instructions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Continue medication as normal prior to endoscopic procedure; Does not withhold incretin therapy, maintains dose/frequency/duration of medication.	Drug: GLP-1 medication; Continue taking GLP-1 as normally scheduled prior to endoscopy.; Other Names: Dulaglutide; Liraglutide; Semaglutide; Tirzepatide
No Intervention: Hold dose prior to endoscopic procedure; Withholds prior dose of incretin therapy per ASA guidance recommendations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of RGV (Residual Gastric Volume) in Stomach	Residual gastric volume (RGV) that precludes adequate endoscopic examination	Procedure
Tracking the Use of Intubation Due to RGV		Procedure
Aspiration Events Due to RGV (Residual Gastric Volume)	Occurrence of aspiration events requiring extended observation/monitoring, unplanned therapeutics, and/or hospital admission	Procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of any solid food	Detection of undigested food	Procedure
Presence of moderate liquid content	Detection of liquid during procedure	Procedure
Increased RGV(Residual Gastric Volume) defined as any amount of solid content or > 0.8 mL/Kg of fluid content (measured from the aspiration/suction canister).	Quantifying RGV(residual gastric volume) during procedure	Procedure
· Differences in primary and secondary outcomes between different medications	Presence of RGV(Residual Gastric Volume) in stomach	Procedure
· Differences in primary and secondary outcomes between different medications	Early termination of procedure due to high RGV(Residual Gastric Volume)	Procedure
· Differences in primary and secondary outcomes between different medications	Tracking the use of intubation due to RGV(Residual Gastric Volume)	Procedure
· Differences in primary and secondary outcomes between different medications	Determination of aspiration events due to RGV(Residual Gastric Volume)	Procedure
· Differences in primary and secondary outcomes between different medications	Detection of undigested food	Procedure
· Differences in primary and secondary outcomes between different medications	Detection of liquid during procedure	Procedure
· Differences in primary and secondary outcomes between different medications	Quantifying RGV(residual gastric volume) during procedure differences between different medications.	Procedure

Collaborators and Investigators

• Sponsor: The Cleveland Clinic

Publications and helpful links

General Publications

• Kobori T, Onishi Y, Yoshida Y, Tahara T, Kikuchi T, Kubota T, Iwamoto M, Sawada T, Kobayashi R, Fujiwara H, Kasuga M. Association of glucagon-like peptide-1 receptor agonist treatment with gastric residue in an esophagogastroduodenoscopy. J Diabetes Investig. 2023 Jun;14(6):767-773. doi: 10.1111/jdi.14005. Epub 2023 Mar 15.
• Silveira SQ, da Silva LM, de Campos Vieira Abib A, de Moura DTH, de Moura EGH, Santos LB, Ho AM, Nersessian RSF, Lima FLM, Silva MV, Mizubuti GB. Relationship between perioperative semaglutide use and residual gastric content: A retrospective analysis of patients undergoing elective upper endoscopy. J Clin Anesth. 2023 Aug;87:111091. doi: 10.1016/j.jclinane.2023.111091. Epub 2023 Mar 2.
• Joshi G, Abdelmalak B, Weigel W, et al. American Society of Anesthesiologists Consensus-Based Guidance on Preoperative Management of Patients (Adults and Children) on Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists. Released June 29, 2023. Accessed from asahq.org on January 16, 2024.

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2024
• Primary Completion (Actual): May 20, 2025
• Study Completion (Actual): May 20, 2025

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: anesthesia; endoscopy; incretin; gastroparesis; glp1; residual gastric volume; ozempic; wegovy; mounjaro
• Additional Relevant MeSH Terms: Neurologic Manifestations; Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Overweight; Paralysis; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Diabetes Mellitus, Type 2; Gastroparesis; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Peptides, and Proteins; Proteins; Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Gastrointestinal Hormones; Glucagon-Like Peptides; Proglucagon; Glucagon-Like Peptide 1; Liraglutide; Tirzepatide; semaglutide; dulaglutide
• Other Study ID Numbers: 24-301

Drug and device information, study documents

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