# Holding vs Continuing GLP-1/GIP Agonists Before Upper Endoscopy: The OCULUS Randomized Clinical Trial

## TL;DR

This study found that continuing GLP-1/GIP agonists before upper endoscopy increases residual gastric volume, but not aspiration events, suggesting they should be held before the procedure.

## Contribution

The study provides high-quality evidence that GLP-1/GIP agonists increase residual gastric volume pre-procedure, guiding clinical management decisions.

## Key findings

- Continuing GLP-1/GIP agonists increased clinically significant residual gastric volume (25.0%) compared to holding them (3.1%).
- Clear liquids the day before the procedure reduced residual gastric volume risk regardless of GLP-1/GIP use.
- No increase in aspiration-related adverse events was observed despite higher residual gastric volume.

## Abstract

Does the use of glucagon-like peptide-1 (GLP-1) or glucose-dependent insulinotropic polypeptide (GIP) agonists have clinically significant effects on residual gastric volume (RGV) in the periprocedural period?

In this randomized clinical trial including 60 US adults with a prespecified interim analysis, the rate of clinically significant RGV was 25.0% vs 3.1% when GLP-1/GIP agonists were continued vs held, respectively, in the periprocedural period. The difference was statistically significant and met the preestablished stopping boundary for study termination.

These results suggest that GLP-1 and GIP agonists treatment increases clinically significant RGV during the periprocedural period; however, there was no concomitant increase in aspiration-related adverse events.

This randomized clinical trial of US adults treated with stable doses of glucagon-like peptide-1 and/or glucose-dependent insulinotropic polypeptide agonists examines the effects on residual gastric volume.

Glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are known to increase the risk of retained gastric contents. High-quality data are lacking to guide periprocedure management of GLP-1 and GIP agonists.

To compare the risk of clinically significant residual gastric volume (RGV) in patients who continue vs hold 1 dose of weekly or daily GLP-1 and GIP agonists prior to sedation.

This randomized, single-masked clinical trial conducted at 2 large tertiary referral centers in the US included patients undergoing elective upper endoscopy (EGD) who were receiving GLP-1 or GLP-1/GIP agonists between July 2024 and May 2025. Eligible participants were adults aged 18 years or older, scheduled for EGD with or without colonoscopy, under moderate sedation or monitored anesthesia care, and taking a stable dose of a GLP-1 or GLP-1/GIP agonist for at least 1 month. Exclusion criteria were prior foregut surgery, achalasia, documented gastroparesis, RGV on previous endoscopy, gastric outlet obstruction, planned general anesthesia, or recent opioid use. Data were analyzed May 2025.

Participants were randomized to either continue their medication or hold 1 dose prior to the procedure.

Clinically significant RGV, a composite of gastric contents that (1) precludes endoscopic examination, (2) requires premature termination or endotracheal intubation, and/or (3) results in an aspiration event that necessitates extended observation or monitoring, unplanned therapeutics, or hospital admission.

There were 60 patients (32 holding 1 dose, 28 continuing medication) in the preplanned interim analysis (median [IQR] age, 62.5 [55.5-67.5] years; 30 female [50.0%]). Clinically significant RGV occurred in 3.1% in the hold group vs 25.0% in the continue group (absolute difference, 21.9% [90% CI, 7.0%-36.7%]; P = .003). The trial was terminated early as risk exceeded the preestablished O’Brien-Fleming stopping boundary. In the EGD-only subgroup (35 patients), clinically significant RGV occurred in 46.7% in the continue vs 5.0% in the hold groups (absolute difference, 41.7% [90% CI, 17.9%-65.4%]; P = .001). In the EGD plus colonoscopy subgroup (25 patients), who were on clear liquids the day prior, no patients had clinically significant RGV.

This randomized clinical trial found that continuing GLP-1 or GIP agonist in the preprocedural period increased clinically significant RGV but did not increase the risk of other adverse events. Clear liquids the day prior to the procedure may mitigate the risk of clinically significant RGV regardless of GLP-1/GIP use.

ClinicalTrials.gov Identifier: NCT06533527