Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy
Randomized Trial of Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy
1 other identifier
interventional
69
1 country
2
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 diabetes-mellitus-type-2
Started Jul 2024
Shorter than P25 for phase_4 diabetes-mellitus-type-2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2024
CompletedStudy Start
First participant enrolled
July 31, 2024
CompletedFirst Posted
Study publicly available on registry
August 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2025
CompletedResults Posted
Study results publicly available
December 5, 2025
CompletedDecember 5, 2025
November 1, 2025
10 months
June 27, 2024
October 17, 2025
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
Continue medication as normal prior to endoscopic procedure
ACTIVE COMPARATORDoes not withhold incretin therapy, maintains dose/frequency/duration of medication.
Hold dose prior to endoscopic procedure
NO INTERVENTIONWithholds prior dose of incretin therapy per ASA guidance recommendations.
Interventions
Continue taking GLP-1 as normally scheduled prior to endoscopy.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Cleveland Clinic
Weston, Florida, 33331, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Related Publications (4)
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: 36919944RESULTSilveira 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.
PMID: 36870274RESULTJoshi 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.
RESULTAhmad 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 Mar 16:e260027. doi: 10.1001/jamainternmed.2026.0027. Online ahead of print.
PMID: 41837981DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Tilak Shah
- Organization
- Cleveland Clinic Florida (Weston Hospital)
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 27, 2024
First Posted
August 1, 2024
Study Start
July 31, 2024
Primary Completion
May 20, 2025
Study Completion
May 20, 2025
Last Updated
December 5, 2025
Results First Posted
December 5, 2025
Record last verified: 2025-11