Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy

Description

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

Conditions

Diabetes Mellitus, Type 2, Obesity, Gastroparesis

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Study Overview

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Study Details

Study 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

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

Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy

Condition
Diabetes Mellitus, Type 2
Intervention / Treatment

-

Contacts and Locations

Weston

Cleveland Clinic, Weston, Florida, United States, 33331

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

The Cleveland Clinic,

Study Record Dates

2025-07