GASTRIC PERORAL ENDOSCOPIC MYOTOMY (GPOEM) VERSUS BOTULINIUM TOXIN INJECTION (BTI) FOR THE TREATMENT OF REFRACTORY GASTROPARESIS: FIRST DOUBLE-BLIND RANDOMIZED CONTROLLED STUDY

Aims This is the first randomized study comparing the clinical efficacy of GPOEM with pyloric BTI in refractory gastroparesis. The aims were to compare the 3-month and 1 year efficacy (GCSI score), GES evolution, adverse events, quality of life (GIQLI and SF-12). Predictive factors were analyzed.

Methods This was a prospective, randomized, double-blind study conducted in two French expert centers. Patients had severe, refractory gastroparesis, evolving for>6 months and confirmed by gastric emptying scintigraphy (GES), and were randomized into two groups: GPOEM and BTI. Follow-up was 1 year.

Results 40 patients were included, 22 women and 18 men, mean age 48.1±17.4 years. Etiologies were diabetic (n=11), idiopathic (n=18), postoperative (n=6), or mixed (n=4). Both groups were comparable at baseline. Clinical success at 3 months and 1 year were 73.3% and 67% in the GPOEM group vs. 53.3% and 57% in the Botox group (p=0.26; p=0.58), respectively. The GCSI deltas were was 1.48±1.17 versus 1.15±0.57 (NS) at 3 months and 1.2±1 versus 0.9±1.2 (NS) at 1 year, respectively. There was no difference in quality of life. Only one minor AE occurred in the GPOEM group. GES improvement rate was 72% after GPOEM against 50% after BTI (NS).

Conclusions This study confirms the results of open studies, showing clinical success of 65% at 1 year for GPOEM. Despite a trend in its favor of GPOEM, no significant difference was demonstrated with BTI. These results should be completed in larger study with greater power.

ESGE Days 2022 Oral presentations

Cutting the (muscular) edge: peroral endoscopic myotomy09:30–10:30

Thursday, 28 April 2022Club A

Publication History

Article published online:
14 April 2022