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.
Kumbhari, V., Sartoretto, A., Boskoski, I., De Moura, D., Badurdeen, D., Maselli, D., De Moura, E., Pontecorvi, V., Abu Dayyeh, B., Mcgowan, C., Safety Framework for Gastric Mucosal Ablation (GMA) Using Hybrid Argon Plasma Coagulation (hAPC): International Expert Consensus, <<OBESITY SURGERY>>, 2026; (may): N/A-N/A. [doi:10.1007/s11695-026-08685-3] [https://hdl.handle.net/10807/340770]
Safety Framework for Gastric Mucosal Ablation (GMA) Using Hybrid Argon Plasma Coagulation (hAPC): International Expert Consensus
Boskoski, Ivo;Maselli, Daniele;Pontecorvi, Valerio;
2026
Abstract
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.| File | Dimensione | Formato | |
|---|---|---|---|
|
safet.pdf
accesso aperto
Tipologia file ?:
Versione Editoriale (PDF)
Licenza:
Creative commons
Dimensione
1.33 MB
Formato
Adobe PDF
|
1.33 MB | Adobe PDF | Visualizza/Apri |
I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.



