GASTRIC PERORAL ENDOSCOPIC MYOTOMY (G-POEM) FOR THE TREATMENT OF REFRACTORY GASTROPARESIS: RESULTS FROM THE FIRST INTERNATIONAL PROSPECTIVE TRIAL

Background: Gastric per-oral endoscopic myotomy (G-POEM)was first reported in 2013 for the treatment of gastroparesis. Early data suggested efficacy of the procedure; however, data from prospective multicenter studies are currently lacking. Aims: To prospectively evaluate the efficacy and safety of G-POEM in patients with gastroparesis refractory to conventional medical treatment. Methods: This is a multicenter study involving 6 tertiary centers (5 US, 1 South America)between 11/2015 and 11/2018. Adult patients with refractory gastroparesis, defined as failing prior conventional medical therapy, and confirmed by gastric emptying study (GES). The primary outcome was clinical success, defined as at least one score decrease in total GCSI with more than a 25% decrease in at least 2 sub-scales. Secondary outcomes were quality of life based on Short Form 36 (SF-36)and improvement of gastric motility assessed by GES. Data were collected before the procedure and 1 month, 3 months, 6 months, and 12 months after the procedure. GES was performed before and after G-POEM. Results: A total of 73 patients with refractory gastroparesis (51 female [70 %]; median age 44yr)underwent G-POEM during the study period. The most common etiologies were idiopathic 29 (39.7 %), post-surgical 26 (35.6 %), and diabetes 18 (24.7 %). All procedures were technically successful. Clinical success was achieved in 57.9 % and 36.8% of patients at 6 and 12 months, respectively. Repeated measures ANOVA showed that the mean GCSI score improved significantly over follow-up intervals (p=0.015). Although the mean GCSI total score improved, the improvement in specific subscales including nausea/vomiting (p=0.17)and bloating (p=0.06)were not statistically significant, while that for early satiety was (p=0.04)(figure 1). Quality of life generally improved after G-POEM. Specifically, physical functioning, social functioning, and health change subscales significantly improved at 12 months post G-PEOM (table 1). Comparison of GES results before and after G-POEM showed that gastric emptying rate normalized in 55% of patients and the mean 4-hr gastric retention percentage decreased significantly from 39.4 ± 20.4 to 18.3 ± 24.8 (p<0.001). A total of 4 AEs occurred: 3 capnoperitoneum and 1 mucosotomy, all rated as mild according to the ASGE lexicon. The 3 capnoperitoneum cases were treated by needle decompression, while the inadvertent mucosotomy was successfully treated by stent deployment. Conclusion: With high technical success rate, limited adverse events, and high clinical efficacy, G-POEM appears to be a feasible and promising therapeutic intervention for management of refractory gastroparesis. [Figure presented][Figure presented]