Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy
NCT ID: NCT06533527
Last Updated: 2025-12-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
69 participants
INTERVENTIONAL
2024-07-31
2025-05-20
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Continue medication as normal prior to endoscopic procedure
Does not withhold incretin therapy, maintains dose/frequency/duration of medication.
GLP-1 medication
Continue taking GLP-1 as normally scheduled prior to endoscopy.
Hold dose prior to endoscopic procedure
Withholds prior dose of incretin therapy per ASA guidance recommendations.
No interventions assigned to this group
Interventions
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GLP-1 medication
Continue taking GLP-1 as normally scheduled prior to endoscopy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients scheduled for outpatient esophagogastroduodenoscopy (EGD), endoscopic ultrasound (EUS), or endoscopic retrograde cholangiopancreatography (ERCP) under monitored anesthesia care.
Exclusion Criteria
* 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.
ALL
Yes
Sponsors
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The Cleveland Clinic
OTHER
Responsible Party
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Shah,Tilak
Principal Investigator
Locations
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Cleveland Clinic
Weston, Florida, United States
Cleveland Clinic
Cleveland, Ohio, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan: Protocol Ver. 5
Other Identifiers
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24-301
Identifier Type: -
Identifier Source: org_study_id
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