Status:
COMPLETED
Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy
Lead Sponsor:
The Cleveland Clinic
Conditions:
Diabetes Mellitus, Type 2
Obesity
Eligibility:
All Genders
Phase:
PHASE4
Brief 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 preclu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2025
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT06533527
Start Date
July 31 2024
End Date
May 20 2025
Last Update
December 5 2025
Active Locations (2)
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1
Cleveland Clinic
Weston, Florida, United States, 33331
2
Cleveland Clinic
Cleveland, Ohio, United States, 44195