Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy

Phase

N/A

Condition

Gastroparesis

Obesity

Diabetes Mellitus, Type 2

Treatment

Dulaglutide

Tirzepatide

Liraglutide

Clinical Study ID

NCT06533527

24-301

All Genders
Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients using incretin-based therapies at a stable dose for more than 1 month.
Patients scheduled for outpatient esophagogastroduodenoscopy (EGD), endoscopicultrasound (EUS), or endoscopic retrograde cholangiopancreatography (ERCP) undermonitored anesthesia care.

Exclusion

Exclusion Criteria:

Documented history of gastroparesis (based on a 4-hour solid-phase gastric emptyingstudy)
Known history of achalasia
Surgical or genetically altered foregut anatomy
Known gastric outlet obstruction or pre-procedure imaging suggestive of gastricoutlet obstruction.
Patients who did not follow the standard NPO (nil per oral) instructions.

Study Design