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To assess whether holding incretin-based therapy before endoscopy reduces the likelihood of clinically relevant Residual Gastric Volume (RGV).
Primary Outcomes:
Secondary Outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continue medication as normal prior to endoscopic procedure | Active Comparator | Does not withhold incretin therapy, maintains dose/frequency/duration of medication. |
|
| Hold dose prior to endoscopic procedure | No Intervention | Withholds prior dose of incretin therapy per ASA guidance recommendations. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLP-1 medication | Drug | Continue taking GLP-1 as normally scheduled prior to endoscopy. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Weston | Florida | 33331 | United States | ||
| Cleveland Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36919944 | Result | 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. | |
| 36870274 |
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One patient was excluded prior to assignment due to having stop the GLP medication prior to randomization.
Adults 18 or older who were scheduled to undergo an upper endoscopic procedure under monitored anesthesia care or moderate sedation were recruited from Cleveland Clinic hospital main campus or Cleveland Clinic Weston. Patients undergoing colonoscopy were permitted to participate if they were also undergoing an upper endoscopic procedure concurrently. Recruitment occurred from July 2024 until May 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | Continue medication as normal prior to endoscopic procedure | Does not withhold incretin therapy, maintains dose/frequency/duration of medication. |
| FG001 | Hold dose prior to endoscopic procedure | Withholds prior dose of incretin therapy per ASA guidance recommendations. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Nine patients met exclusion criteria and not included in analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Continue Medication as Normal Prior to Endoscopic Procedure | Does not withhold incretin therapy, maintains dose/frequency/duration of medication. |
| BG001 | Hold Dose Prior to Endoscopic Procedure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Presence of RGV (Residual Gastric Volume) in Stomach | Residual gastric volume (RGV) that precludes adequate endoscopic examination | Posted | Count of Participants | Participants | Procedure |
|
Adverse events collected from the time of the endoscopy procedure up to one week after the procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Continue medication as normal prior to endoscopic procedure | Does not withhold incretin therapy, maintains dose/frequency/duration of medication. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tilak Shah | Cleveland Clinic Florida (Weston Hospital) | 954-659-5646 | shaht3@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Protocol Ver. 5 | Feb 3, 2025 | Oct 16, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| C000591245 | semaglutide |
| D000069450 | Liraglutide |
| C555680 | dulaglutide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
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| Cleveland |
| Ohio |
| 44195 |
| United States |
| 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. |
| Result | 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. |
| 41837981 | Derived | Ahmad AI, Garg S, Jacobs J, Ansari Z, Al-Din TJ, Almomani A, Valencia S, Vargo J, Chatterjee A, Siddiki H, Hong L, Nicolas MA, Miller A, Shah T. Holding vs Continuing GLP-1/GIP Agonists Before Upper Endoscopy: The OCULUS Randomized Clinical Trial. JAMA Intern Med. 2026 May 1;186(5):578-584. doi: 10.1001/jamainternmed.2026.0027. |
Withholds prior dose of incretin therapy per ASA guidance recommendations.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Diabetes | Number of patients with diagnosed with Diabetes Mellitus | Count of Participants | Participants |
|
| A1c greater than 7 | Percent of glycated hemoglobin | Count of Participants | Participants |
|
| A1c | Median A1c of participants | Median | Full Range | Percent of glycated hemoglobin |
|
| BMI | Median | Full Range | kg/m^2 |
|
| Drug type | What GLP medication is patient taking | Count of Participants | Participants |
|
| Duration on drug | Length of time patient has been taking GLP-1 medication (months) | Median | Full Range | months |
|
| Indications for the Procedure | Some participants may have multiple indications for the procedure while some may have no indication. This results in a difference between the total number of participants and the number of indications reported. | Count of Participants | Participants | No |
|
| Preprocedural symptoms | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Tracking the Use of Intubation Due to RGV | Posted | Count of Participants | Participants | Procedure |
|
|
|
| Primary | Aspiration Events Due to RGV (Residual Gastric Volume) | Occurrence of aspiration events requiring extended observation/monitoring, unplanned therapeutics, and/or hospital admission | Posted | Number | number of aspiration events | Procedure |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Hold dose prior to endoscopic procedure | Withholds prior dose of incretin therapy per ASA guidance recommendations. | 0 | 32 | 0 | 32 | 0 | 32 |
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| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |