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

The Cleveland Clinic1 site in 1 country69 target enrollmentJuly 31, 2024

Overview

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

Registry

clinicaltrials.gov

Start Date

July 31, 2024

End Date

May 20, 2025

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Principal Investigator

Shah,Tilak

Principal Investigator

The Cleveland Clinic

•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.

•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.