Safety Framework for Gastric Mucosal Ablation (GMA) Using Hybrid Argon Plasma Coagulation (hAPC): International Expert Consensus.

BACKGROUND

Gastric mucosal ablation (GMA) using hybrid argon plasma coagulation (hAPC) is an investigational endoscopic technique that selectively devitalizes ghrelin-producing gastric mucosa to modulate appetite-regulating pathways. As clinical investigation extends beyond early trials, a standardized safety framework is needed to support responsible implementation.

METHODS

An international panel of investigators with direct procedural experience in GMA (> 300 procedures collectively) developed consensus safety recommendations using a modified Delphi process. Formal systematic review with GRADE assessment was not undertaken, as the nascent evidence does not support such evaluation. Consensus was defined as ≥ 75% agreement among panelists. Recommendations were classified by consensus strength (high ≥ 80%, moderate 60-79%, low 51-59%) reflecting the degree of panel agreement rather than formal certainty of evidence.

RESULTS

The panel identified nine procedural and post-procedural domains important for the safe execution of GMA. These include: (1) cold saline submucosal injection to elevate the mucosa; (2) ablation precisely confined to the elevated zone; (3) ablation limited to 5 mm from the edge of each fluid cushion; (4) APC energy delivery limited to ≤ 40 W; (5) judicious evacuation of argon gas throughout the procedure; (6) high-dose proton pump inhibitor therapy for a minimum of four weeks; (7) sucralfate for four weeks; (8) gradual post-procedure dietary advancement; and (9) operator credentialing, including proctoring until proficiency is demonstrated.

CONCLUSIONS

This consensus-driven framework for GMA provides preliminary safety guidance for clinical investigation and may serve as a model for other emerging endoscopic metabolic therapies.