Gastric Peroral Endoscopic Myotomy versus Botulinum Toxin injection for the treatment of refractory gastroparesis: results of a double-blind randomized controlled study

Introduction: G-POEM is a promising technique for treating refractory gastroparesis. We present the first double-blind randomized study comparing the clinical efficacy of G-POEM versus pyloric Botulinum Toxin injection (BTI). Materials and Methods: This randomized study was conducted in two expert centers. Patients enrolled had refractory gastroparesis, medically managed for > 6 months and confirmed by gastric emptying scintigraphy (GES). Two groups were randomized: G-POEM and BTI, with follow-up of 1 year. The primary endpoint was the 3-month and 1-year clinical efficacy, defined as the decreasing of the mean Gastroparesis Cardinal Symptom Index (GCSI) score. Secondary endpoints were GES evolution, adverse events, quality of life (GIQLI and SF-12). Results: 40 patients (22 women,18 men) of mean age 48.1 ± 17.4 years were randomized. Mean symptoms duration was 5.8 ± 5.7 years. Etiologies were diabetic (n=11), idiopathic (n=18), postoperative (n=6), or mixed (n=4). The 3-months clinical success was higher in the G-POEM group versus BTI (65% versus 40%, respectively, p=0.15). The 1-year clinical success, in intention-to-treat analysis, was also higher (60% vs. 40%, respectively) but not significantly. The GCSI decreased in both groups at 3 months and 1 year. Only one minor AE occurred in G-POEM group. GES improvement rate was 72% in the G-POEM group versus 50% in the BTI group (NS). Conclusion: G-POEM seems to have higher clinically relevant success rate than BTI, but not statistically demonstrated. Anyway, this study confirms the interest of treatments targeting the pylorus, either mechanically or chemically, for managing refractory gastroparesis.