{"protocolSection":{"identificationModule":{"nctId":"NCT06533527","orgStudyIdInfo":{"id":"24-301"},"organization":{"fullName":"The Cleveland Clinic","class":"OTHER"},"briefTitle":"Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy","officialTitle":"Randomized Trial of Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy"},"statusModule":{"statusVerifiedDate":"2025-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2024-07-31","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2025-05-20","type":"ACTUAL"},"completionDateStruct":{"date":"2025-05-20","type":"ACTUAL"},"studyFirstSubmitDate":"2024-06-27","studyFirstSubmitQcDate":"2024-07-30","studyFirstPostDateStruct":{"date":"2024-08-01","type":"ACTUAL"},"resultsFirstSubmitDate":"2025-10-17","resultsFirstSubmitQcDate":"2025-11-17","resultsFirstPostDateStruct":{"date":"2025-12-05","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-11-17","lastUpdatePostDateStruct":{"date":"2025-12-05","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Shah,Tilak","investigatorTitle":"Principal Investigator","investigatorAffiliation":"The Cleveland Clinic"},"leadSponsor":{"name":"The Cleveland Clinic","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"To assess whether holding incretin-based therapy before endoscopy reduces the likelihood of clinically relevant Residual Gastric Volume (RGV).\n\nPrimary Outcomes:\n\n* Residual gastric volume that precludes adequate endoscopic examination\n* Residual gastric volume that necessitates premature termination of the endoscopy procedure\n* Need for endotracheal intubation due to stomach contents.\n* Occurrence of aspiration events requiring extended observation/monitoring, unplanned therapeutics, and/or hospital admission\n\nSecondary Outcomes:\n\n* Presence of any solid food\n* Presence of moderate liquid content\n* 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).\n* Differences in primary and secondary outcomes between different medications"},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2","Obesity","Gastroparesis"],"keywords":["incretin","wegovy","ozempic","mounjaro","glp1","gastroparesis","residual gastric volume","endoscopy","anesthesia"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"HEALTH_SERVICES_RESEARCH","maskingInfo":{"masking":"DOUBLE","whoMasked":["CARE_PROVIDER","INVESTIGATOR"]}},"enrollmentInfo":{"count":69,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Continue medication as normal prior to endoscopic procedure","type":"ACTIVE_COMPARATOR","description":"Does not withhold incretin therapy, maintains dose/frequency/duration of medication.","interventionNames":["Drug: GLP-1 medication"]},{"label":"Hold dose prior to endoscopic procedure","type":"NO_INTERVENTION","description":"Withholds prior dose of incretin therapy per ASA guidance recommendations."}],"interventions":[{"type":"DRUG","name":"GLP-1 medication","description":"Continue taking GLP-1 as normally scheduled prior to endoscopy.","armGroupLabels":["Continue medication as normal prior to endoscopic procedure"],"otherNames":["Tirzepatide","Semaglutide","Liraglutide","Dulaglutide"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Presence of RGV (Residual Gastric Volume) in Stomach","description":"Residual gastric volume (RGV) that precludes adequate endoscopic examination","timeFrame":"Procedure"},{"measure":"Tracking the Use of Intubation Due to RGV","timeFrame":"Procedure"},{"measure":"Aspiration Events Due to RGV (Residual Gastric Volume)","description":"Occurrence of aspiration events requiring extended observation/monitoring, unplanned therapeutics, and/or hospital admission","timeFrame":"Procedure"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Patients using incretin-based therapies at a stable dose for more than 1 month.\n* Patients scheduled for outpatient esophagogastroduodenoscopy (EGD), endoscopic ultrasound (EUS), or endoscopic retrograde cholangiopancreatography (ERCP) under monitored anesthesia care.\n\nExclusion Criteria:\n\n* Documented history of gastroparesis (based on a 4-hour solid-phase gastric emptying study)\n* Known history of achalasia\n* Surgical or genetically altered foregut anatomy\n* Known gastric outlet obstruction or pre-procedure imaging suggestive of gastric outlet obstruction.\n* Patients who did not follow the standard NPO (nil per oral) instructions.","healthyVolunteers":true,"sex":"ALL","stdAges":["CHILD","ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"Cleveland Clinic","city":"Weston","state":"Florida","zip":"33331","country":"United States","geoPoint":{"lat":26.10037,"lon":-80.39977}},{"facility":"Cleveland Clinic","city":"Cleveland","state":"Ohio","zip":"44195","country":"United States","geoPoint":{"lat":41.4995,"lon":-81.69541}}]},"referencesModule":{"references":[{"pmid":"36919944","type":"RESULT","citation":"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."},{"pmid":"36870274","type":"RESULT","citation":"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."},{"type":"RESULT","citation":"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."},{"pmid":"41837981","type":"DERIVED","citation":"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."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"One patient was excluded prior to assignment due to having stop the GLP medication prior to randomization.","recruitmentDetails":"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.","groups":[{"id":"FG000","title":"Continue medication as normal prior to endoscopic procedure","description":"Does not withhold incretin therapy, maintains dose/frequency/duration of medication."},{"id":"FG001","title":"Hold dose prior to endoscopic procedure","description":"Withholds prior dose of incretin therapy per ASA guidance recommendations."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"28"},{"groupId":"FG001","numSubjects":"32"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"28"},{"groupId":"FG001","numSubjects":"32"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Nine patients met exclusion criteria and not included in analysis","groups":[{"id":"BG000","title":"Continue Medication as Normal Prior to Endoscopic Procedure","description":"Does not withhold incretin therapy, maintains dose/frequency/duration of medication."},{"id":"BG001","title":"Hold Dose Prior to Endoscopic Procedure","description":"Withholds prior dose of incretin therapy per ASA guidance recommendations."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"60"}]}],"measures":[{"title":"Age, 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Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"60"}]}],"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"30"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"17"},{"groupId":"BG002","value":"30"}]}]}]},{"title":"Race and Ethnicity Not Collected","populationDescription":"Race and Ethnicity were not collected from any participant.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}],"categories":[{"measurements":[{"groupId":"BG002","value":"0"}]}]}]},{"title":"Diabetes","populationDescription":"Number of patients with diagnosed with Diabetes Mellitus","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"60"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"17"}]}]}]},{"title":"A1c greater than 7","description":"Percent of glycated hemoglobin","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"60"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"13"}]}]}]},{"title":"A1c","description":"Median A1c of participants","paramType":"MEDIAN","dispersionType":"FULL_RANGE","unitOfMeasure":"Percent of glycated hemoglobin","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"60"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"6.4","lowerLimit":"5","upperLimit":"10.6"},{"groupId":"BG001","value":"6.4","lowerLimit":"4.8","upperLimit":"9.2"},{"groupId":"BG002","value":"6.4","lowerLimit":"4.8","upperLimit":"10.6"}]}]}]},{"title":"BMI","paramType":"MEDIAN","dispersionType":"FULL_RANGE","unitOfMeasure":"kg/m^2","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"60"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"31.0","lowerLimit":"20.2","upperLimit":"40.9"},{"groupId":"BG001","value":"29.7","lowerLimit":"23.6","upperLimit":"49.9"},{"groupId":"BG002","value":"30","lowerLimit":"20.2","upperLimit":"49.9"}]}]}]},{"title":"Drug type","description":"What GLP medication is patient taking","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Dulaglutide","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"60"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"7"}]}]},{"title":"Semaglutide","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"60"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"30"}]}]},{"title":"Tirzepatide","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"60"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"23"}]}]}]},{"title":"Duration 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This results in a difference between the total number of participants and the number of indications 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