Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy

November 17, 2025 updated by: Shah,Tilak, The Cleveland Clinic

Randomized Trial of Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Weston, Florida, United States, 33331
        • Cleveland Clinic
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Continue medication as normal prior to endoscopic procedure
Does not withhold incretin therapy, maintains dose/frequency/duration of medication.
Drug: GLP-1 medication
Continue taking GLP-1 as normally scheduled prior to endoscopy.
Other Names:
  • Dulaglutide
  • Liraglutide
  • Semaglutide
  • Tirzepatide
No Intervention: Hold dose prior to endoscopic procedure
Withholds prior dose of incretin therapy per ASA guidance recommendations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of RGV (Residual Gastric Volume) in Stomach
Time Frame: Procedure
Residual gastric volume (RGV) that precludes adequate endoscopic examination
Procedure
Tracking the Use of Intubation Due to RGV
Time Frame: Procedure
Procedure
Aspiration Events Due to RGV (Residual Gastric Volume)
Time Frame: Procedure
Occurrence of aspiration events requiring extended observation/monitoring, unplanned therapeutics, and/or hospital admission
Procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of any solid food
Time Frame: Procedure
Detection of undigested food
Procedure
Presence of moderate liquid content
Time Frame: Procedure
Detection of liquid during procedure
Procedure
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).
Time Frame: Procedure
Quantifying RGV(residual gastric volume) during procedure
Procedure
· Differences in primary and secondary outcomes between different medications
Time Frame: Procedure
Presence of RGV(Residual Gastric Volume) in stomach
Procedure
· Differences in primary and secondary outcomes between different medications
Time Frame: Procedure
Early termination of procedure due to high RGV(Residual Gastric Volume)
Procedure
· Differences in primary and secondary outcomes between different medications
Time Frame: Procedure
Tracking the use of intubation due to RGV(Residual Gastric Volume)
Procedure
· Differences in primary and secondary outcomes between different medications
Time Frame: Procedure
Determination of aspiration events due to RGV(Residual Gastric Volume)
Procedure
· Differences in primary and secondary outcomes between different medications
Time Frame: Procedure
Detection of undigested food
Procedure
· Differences in primary and secondary outcomes between different medications
Time Frame: Procedure
Detection of liquid during procedure
Procedure
· Differences in primary and secondary outcomes between different medications
Time Frame: Procedure
Quantifying RGV(residual gastric volume) during procedure differences between different medications.
Procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2024

Primary Completion (Actual)

May 20, 2025

Study Completion (Actual)

May 20, 2025

Study Registration Dates

First Submitted

June 27, 2024

First Submitted That Met QC Criteria

July 30, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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