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

Summary

In this single-masked randomized trial (interim n=60), holding one dose of GLP-1/GIP agonists before elective upper endoscopy significantly reduced clinically significant residual gastric volume versus continuing therapy, meeting an early stopping boundary. The absolute risk difference was 21.9% overall, with the greatest effect in EGD-only cases; clear liquids the day prior mitigated risk in combined EGD+colonoscopy.

Key Findings

• Clinically significant residual gastric volume occurred in 3.1% (hold) vs 25.0% (continue); absolute difference 21.9% (90% CI, 7.0%-36.7%; P=.003).
• EGD-only subgroup: 5.0% (hold) vs 46.7% (continue); absolute difference 41.7% (P=.001).
• No clinically significant RGV events in EGD+colonoscopy patients on clear liquids the day prior.
• Trial was stopped early per O’Brien-Fleming boundary due to excess risk in the continue arm.

Clinical Implications

For elective upper endoscopy under moderate sedation/MAC, advise holding one dose of weekly/daily GLP-1/GIP agonists when feasible, especially for EGD-only cases; consider a clear-liquid day prior to mitigate risk if combining with colonoscopy.

Limitations

• Interim analysis with small sample size (n=60) and early termination may overestimate effect size
• Single-masked design and two-center setting may limit generalizability

Future Directions

Confirm findings in larger, multicenter trials across procedure types and anesthesia depths; define standardized fasting/clear-liquid protocols and medication-hold intervals by agent half-life.