ObjectiveAlthough gastric per-oral endoscopic myotomy (G-POEM) is considered a promising technique for the management of refractory gastroparesis, high-quality evidence is limited. We prospectively investigated the efficacy and safety of G-POEM in unselected patients with refractory gastroparesis.DesignIn five tertiary centres, patients with symptomatic gastroparesis refractory to standard medical therapy and confirmed by impaired gastric emptying were included. The primary endpoint was clinical success, defined as at least one score decrease in Gastroparesis Cardinal Symptom Index (GCSI) with ≥25% decrease in two subscales, at 12 months. GCSI Score and subscales, adverse events (AEs) and 36-Item Short Form questionnaire of quality of life were evaluated at baseline and 1, 3, 6 and 12 months after G-POEM. Gastric emptying study was performed before and 3 months after the procedure.ResultsOf 80 enrolled patients, 75 patients (94%) completed 12-month follow-up. Clinical success at 12 months was 56% (95% CI, 44.8 to 66.7). GCSI Score (including subscales) improved moderately after G-POEM (p<0.05). In a regression model, a baseline GCSI Score >2.6 (OR=3.23, p=0.04) and baseline gastric retention >20% at 4 hours (OR=3.65, p=0.03) were independent predictors of clinical success at 12 months, as was early response to G-POEM at 1 month after therapy (OR 8.75, p<0.001). Mild procedure-related AEs occurred in 5 (6%) patients.ConclusionG-POEM is a safe procedure, but showed only modest overall effectiveness in the treatment of refractory gastroparesis. Further studies are required to identify the best candidates for G-POEM; unselective use of this procedure should be discouraged.Trial registration numberClinicalTrials.gov Registry NCT02732821.

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Background and study aims Minimally invasive procedures that replicate aspects of bariatric surgery with more favorable safety and tolerability offer an attractive alternative in management of metabolic disease. Duodenal mucosal resurfacing (DMR), an endoscopic procedure using hydrothermal ablation, is designed to remove surface epithelium to allow subsequent epithelial regeneration and a reset to a more insulin-sensitive state. Materials and methods DMR was performed on a healthy pig under general anethesia, approximating the procedure designed for use in humans. Immediately post-DMR, analysis of the histological landscape was conducted in distinct duodenal areas that received ablation treatment. Results DMR submucosal lift and hydrothermal ablation elicited disruption of villous tips and partial disruption of the crypt base with no damage to deeper tissue. Excessive ablation (purposeful double ablation exposure) did incur damage to the underlying muscle layer. Conclusion Our results confirmed that DMR elicits superficial ablation of duodenal villi and crypts. Defining the cellular consequences of ablation and regeneration of the epithelium will aid our understanding of how and why DMR affects metabolic homeostasis.