Update data: A pilot study to evaluate the efficacy and safety of Gastric Mucosal Ablation (GMA) of the fundus with Hybrid Argon Plasma Coagulation (HybridAPC) combined with Endoscopic Sleeve Gastroplasty (ESG) in obese patients

Aims To evaluate the efficacy and safety of Hybrid Argon Plasma Coagulation (HybridAPC) for gastric mucosa ablation of the fundus (GMA) in patients undergoing endoscopic sleeve gastroplasty (ESG). To demonstrate how eradication of ghrelin in the fundus with GMA could be a promising approach for ghrelin reduction and improved weight control in the management of obese patients.

Methods Pilot, interventional and single-center study. Subjects with a BMI between≥30 and≤39.9 kg/m2 will be considered eligible for the study. A multidisciplinary team evaluation will be performed for each patients to confirm procedure eligibility. Overall, the study duration will be of 18 months. All endoscopic procedures will be performed with the patient in the supine position, under general anesthesia, with endotracheal intubation, in CO2 using a flexible endoscopic suturing system connected to a dual-channel endoscope. The HybridAPC will be applied to the gastric fundus post ESG procedure in the course of the same treatment session. Patients will be followed up with follow-up visits at 1, 6 and 12 months after ESG and HybridAPC is performed. At each of these visits vital signs, body weight and height will be measured. We will collect blood samples (for total ghrelin, leptin and GLP-1), baseline biochemical data (complete blood count, lipid profile, metabolic profile). Quality of life will be assessed at each visit using the BAROS, SF-36 and IWQOL-Lite-CT questionnaire. Gastroscopy (EGDS) with gastric fundus biopsies will be performed the day of procedure, at 6 and 12 months after ESG. The baseline assessments of variables are being compared with post treatment assessments during the described time points of the follow up period with the aim to measure the effect of additional gastric mucosa ablation in the fundus by HybridAPC.

Results From October 2023 to October 2024 22 patients have been enrolled. All patients underwent endoscopic sleeve gastroplasty and were discharged in good general clinical condition the day after the procedure. No adverse effects were observed. At 6 months follow up the TBWL% was 18,64% for 13 patients.

Conclusions Gastric fundus mucosal ablation with Argon Plasma Coagulation (APC) in obese patients undergoing ESG is a safe procedure. Indeed, Hybrid-APC gastric mucosal ablation could stimulate the fundus stem cells to produce new ghrelin-secreting endocrine cells and this could improve the long terms outcomes in terms of body weight loss and comorbidity reduction in obese patients underwent ESG.

Publication History

Article published online:
27 March 2025