Introduction
Gastroparesis is a chronic disorder characterised by delayed gastric emptying without mechanical obstruction, leading to symptoms such as nausea, vomiting, early satiety, bloating, and postprandial fullness. Treatment options for severe and refractory gastroparesis are limited and often ineffective.
Gastric per-oral endoscopic pyloromyotomy (G-POEM) is a minimally invasive endoscopic technique that divides pyloric muscle fibres to improve gastric emptying. Although observational studies have shown promising results, high-quality randomised evidence has been limited.
Summary
This randomised sham-controlled pilot trial evaluated the efficacy of G-POEM in severe gastroparesis.
A total of 41 patients with refractory gastroparesis (diabetic, postsurgical, or idiopathic) were randomised to G-POEM (n=21) or sham procedure (n=20). The primary endpoint was treatment success, defined as a ≥50% reduction in the Gastroparesis Cardinal Symptom Index (GCSI) at 6 months.
Key findings:
Treatment success:
71% with G-POEM vs 22% with sham (p = 0.005)
By aetiology:
Diabetic gastroparesis: 89% response
Postsurgical gastroparesis: 50% response
Idiopathic gastroparesis: 67% response
Gastric emptying:
Median 4-hour gastric retention improved from 22% to 12% after G-POEM,
No significant change after sham.
Crossover results:
Among 12 sham patients crossing over to G-POEM, 75% achieved symptom improvement.
Clinical Takeaway
This sham-controlled randomised trial demonstrates that G-POEM significantly improves symptoms and gastric emptying in severe refractory gastroparesis, particularly in diabetic cases. However, results remain less conclusive in idiopathic and postsurgical gastroparesis, and larger trials are required to confirm long-term benefits.