Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy

NeuroTherapia, Inc.

Status and phase

Suspended

Phase 4

Conditions

Gastroparesis

Obesity

Diabetes Mellitus, Type 2

Treatments

Drug: Liraglutide

Drug: Semaglutide

Drug: Tirzepatide

Drug: Dulaglutide

Study type

Interventional

Funder types

Other

Identifiers

24-301

Details and patient eligibility

About

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

Enrollment

60 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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.