Esophagus to Small Intestine
Endoscopic pyloromyotomy for the treatment of severe and refractory gastroparesis: A pilot, randomized, sham-controlled trial
Objective: Endoscopic pyloromyotomy (G-POEM) is a minimally invasive treatment option with promising uncontrolled outcome results in patients with gastroparesis.
Design: In this prospective randomized trial, the authors compared G-POEM with a sham procedure in patients with severe gastroparesis. The primary outcome was the proportion of patients with treatment success (defined as a decrease in the Gastroparesis Cardinal Symptom Index [GCSI] by at least 50%) at 6 months. Patients randomized to the sham group with persistent symptoms were offered cross-over G-POEM.
Results: The enrolment was stopped after the interim analysis by the Data and Safety Monitoring Board prior to reaching the planned sample of 86 patients. A total of 41 patients (17 diabetic, 13 postsurgical, 11 idiopathic; 46% male) were randomized (21 G-POEM, 20 sham). Treatment success rate was 71% (95% confidence interval [CI]: 50–86) after G-POEM versus 22% (95% CI: 8–47) after sham (p = 0.005). Treatment success in patients with diabetic, postsurgical and idiopathic gastroparesis was 89% (95% CI: 56–98), 50% (95% CI: 18–82) and 67% (95% CI: 30–90) after G-POEM; the corresponding rates in the sham group were 17% (95% CI: 3–57), 29% (95% CI: 7–67) and 20% (95% CI: 3–67). Median gastric retention at 4 hours decreased from 22% (95% CI: 17–31) to 12% (95% CI: 5–22) after G-POEM and did not change after sham: 26% (95% CI: 18–39) versus 24% (95% CI: 11–35). 12 patients crossed over to G-POEM with 9 of them (75%) achieving treatment success.
Conclusion: In severe gastroparesis, endoscopic pyloromyotomy is superior to a sham procedure for improving both symptoms and gastric emptying 6 months after the procedure. These results are not entirely conclusive in patients with idiopathic and postsurgical etiologies.