Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy

NeuroTherapia, Inc.

Status: Enrolling

Conditions: Gastroparesis; Obesity; Diabetes Mellitus, Type 2

Treatments: Drug: Liraglutide; Drug: Semaglutide; Drug: Tirzepatide; Drug: Dulaglutide

Study type: Interventional

Funder types: Other

Identifiers

NCT06533527

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: 120 estimated 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Continue medication as normal prior to endoscopic procedure

Active Comparator group

Description:

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

Treatment:

Drug: Dulaglutide

Drug: Tirzepatide

Drug: Liraglutide

Drug: Semaglutide

Hold dose prior to endoscopic procedure

No Intervention group

Description:

Withholds prior dose of incretin therapy per ASA guidance recommendations.