Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy
- Conditions
- Diabetes Mellitus, Type 2ObesityGastroparesis
- Interventions
- Registration Number
- NCT06533527
- Lead Sponsor
- The Cleveland Clinic
- 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 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Continue medication as normal prior to endoscopic procedure Semaglutide Does not withhold incretin therapy, maintains dose/frequency/duration of medication. Continue medication as normal prior to endoscopic procedure Tirzepatide Does not withhold incretin therapy, maintains dose/frequency/duration of medication. Continue medication as normal prior to endoscopic procedure Dulaglutide Does not withhold incretin therapy, maintains dose/frequency/duration of medication. Continue medication as normal prior to endoscopic procedure Liraglutide Does not withhold incretin therapy, maintains dose/frequency/duration of medication.
- Primary Outcome Measures
Name Time Method Residual gastric volume(RGV) that precludes adequate endoscopic examination Procedure Presence of RGV(Residual Gastric Volume) in stomach
Residual gastric volume(RGV) that necessitates premature termination of the endoscopy procedure Procedure Early termination of procedure due to high RGV(Residual Gastric Volume)
Need for endotracheal intubation due to stomach contents. Procedure Tracking the use of intubation due to RGV
Occurrence of aspiration events requiring extended observation/monitoring, unplanned therapeutics, and/or hospital admission Procedure Determination of aspiration events due to RGV(Residual Gastric Volume)
- Secondary Outcome Measures
Name Time Method Presence of any solid food Procedure Detection of undigested food
· Differences in primary and secondary outcomes between different medications Procedure Quantifying RGV(residual gastric volume) during procedure differences between different medications.
Presence of moderate liquid content Procedure Detection of liquid during procedure
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). Procedure Quantifying RGV(residual gastric volume) during procedure
Trial Locations
- Locations (1)
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States