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Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy

NeuroTherapia, Inc. logo

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

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

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.

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Tilak Shah, MD; Akram Ahmad, MD

Data sourced from clinicaltrials.gov

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