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Assessment of Plasma Coagulation on Liver Tissue in a Large Animal Model In Vivo
Published on: August 4, 2018
Safety Framework for Gastric Mucosal Ablation (GMA) Using Hybrid Argon Plasma Coagulation (hAPC): International
Vivek Kumbhari1, Adrian Sartoretto2, Ivo Boskoski3
1Division of Gastroenterology and Hepatology, Mayo Clinic, Florida, USA. vkumbhari@gmail.com.
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.
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