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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy

NCTNCT06533527 (opens ClinicalTrials.gov in a new tab)Other id24-301
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
69 participants (actual)
Sponsor
The Cleveland Clinic · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
31 Jul 2024
Primary completion
20 May 2025
Completion
20 May 2025
First posted
1 Aug 2024
Last update posted
5 Dec 2025
Conditions
Diabetes Mellitus, Type 2 · Obesity · Gastroparesis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026
  1. Ph 4

    Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy

    NCT06533527

    31 Jul 2024 to 20 May 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • GLP-1 medicationDrug

Arms2

  • Active comparator

    Continue medication as normal prior to endoscopic procedure

    Does not withhold incretin therapy, maintains dose/frequency/duration of medication.

  • No intervention

    Hold dose prior to endoscopic procedure

    Withholds prior dose of incretin therapy per ASA guidance recommendations.

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Presence of RGV (Residual Gastric Volume) in Stomach

    Time frame · Procedure

    Registry description

    Residual gastric volume (RGV) that precludes adequate endoscopic examination

  2. Tracking the Use of Intubation Due to RGV

    Time frame · Procedure

  3. Aspiration Events Due to RGV (Residual Gastric Volume)

    Time frame · Procedure

    Registry description

    Occurrence of aspiration events requiring extended observation/monitoring, unplanned therapeutics, and/or hospital admission

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Procedure

Presence of RGV (Residual Gastric Volume) in Stomach

GroupValue (Participants)
Continue medication as normal prior to endoscopic procedure7
Hold dose prior to endoscopic procedure1
Primary outcomeCount of participants· Procedure

Tracking the Use of Intubation Due to RGV

GroupValue (Participants)
Continue medication as normal prior to endoscopic procedure0
Hold dose prior to endoscopic procedure0
Primary outcomeNumber· Procedure

Aspiration Events Due to RGV (Residual Gastric Volume)

GroupValue (number of aspiration events)
Continue medication as normal prior to endoscopic procedure0
Hold dose prior to endoscopic procedure0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Continue medication as normal prior to endoscopic procedureDoes not withhold incretin therapy, maintains dose/frequency/duration of medication.0 / 280 / 280 / 28
Hold dose prior to endoscopic procedureWithholds prior dose of incretin therapy per ASA guidance recommendations.0 / 320 / 320 / 32

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

More studies

2 studies on this page

PubMed tag: none · 2023

Relationship between perioperative semaglutide use and residual gastric content: A retrospective analysis of patients undergoing elective upper endoscopy.

Silveira et al. 2023Journal of clinical anesthesiacited by 198

PMID 36870274DOI 10.1016/j.jclinane.2023.111091PUB-36870274

Full text at the publisher
Publisher page

PubMed tag: none · 2023

Association of glucagon-like peptide-1 receptor agonist treatment with gastric residue in an esophagogastroduodenoscopy.

Kobori et al. 2023Journal of diabetes investigationcited by 122

PMID 36919944PMC10204182DOI 10.1111/jdi.14005PUB-36919944

Free to read · publisher termsCC BY-NC
Read at source

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultJoshi 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.
  • DerivedAhmad 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. PMID 41837981

Eligibility

Who could join, as posted.

Sex
All
Age
Not stated
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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