Clinical trial NCT06533527: Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy
Official title: Randomized Trial of Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Obesity
Gastroparesis
Keywords: incretin
wegovy
ozempic
mounjaro
glp1
gastroparesis
residual gastric volume
endoscopy
anesthesia
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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


Eligibility criteria: 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.

Primary outcomes:
measure: Residual gastric volume(RGV) that precludes adequate endoscopic examination
timeFrame: Procedure
measure: Residual gastric volume(RGV) that necessitates premature termination of the endoscopy procedure
timeFrame: Procedure
measure: Need for endotracheal intubation due to stomach contents.
timeFrame: Procedure
measure: Occurrence of aspiration events requiring extended observation/monitoring, unplanned therapeutics, and/or hospital admission
timeFrame: Procedure
Secondary outcomes:
measure: Presence of any solid food
timeFrame: Procedure
measure: Presence of moderate liquid content
timeFrame: Procedure
measure: 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).
timeFrame: Procedure
measure: · Differences in primary and secondary outcomes between different medications
timeFrame: Procedure
measure: · Differences in primary and secondary outcomes between different medications
timeFrame: Procedure
measure: · Differences in primary and secondary outcomes between different medications
timeFrame: Procedure
measure: · Differences in primary and secondary outcomes between different medications
timeFrame: Procedure
measure: · Differences in primary and secondary outcomes between different medications
timeFrame: Procedure
measure: · Differences in primary and secondary outcomes between different medications
timeFrame: Procedure
measure: · Differences in primary and secondary outcomes between different medications
timeFrame: Procedure
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic
state: Florida
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
References:
citation: Kobori T, Onishi Y, Yoshida Y, Tahara T, Kikuchi T, Kubota T, Iwamoto M, Sawada T, Kobayashi R, Fujiwara H, Kasuga M. Association of glucagon-like peptide-1 receptor agonist treatment with gastric residue in an esophagogastroduodenoscopy. J Diabetes Investig. 2023 Jun;14(6):767-773. doi: 10.1111/jdi.14005. Epub 2023 Mar 15.
citation: Silveira SQ, da Silva LM, de Campos Vieira Abib A, de Moura DTH, de Moura EGH, Santos LB, Ho AM, Nersessian RSF, Lima FLM, Silva MV, Mizubuti GB. Relationship between perioperative semaglutide use and residual gastric content: A retrospective analysis of patients undergoing elective upper endoscopy. J Clin Anesth. 2023 Aug;87:111091. doi: 10.1016/j.jclinane.2023.111091. Epub 2023 Mar 2.
citation: Joshi G, Abdelmalak B, Weigel W, et al. American Society of Anesthesiologists Consensus-Based Guidance on Preoperative Management of Patients (Adults and Children) on Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists. Released June 29, 2023. Accessed from asahq.org on January 16, 2024.