EXPRESS: The Long-Term Outcomes of Combining Pyloroplasty with Gastric Electrical Stimulation in Drug-Refractory Gastroparesis: A prospective single-arm trial.

Abstract

Surgical treatments for drug-refractory gastroparesis (GP) include gastric electrical stimulation (GES) and pyloric interventions. No longitudinal studies have evaluated the clinical outcomes and safety of combined GES and pyloroplasty (PP). We aimed to investigate the long-term clinical effectiveness of concurrent utilization of GES and PP in gastroparesis. Forty-nine gastroparetics (35 female; 38 diabetics [DM]) were enrolled and followed up. Baseline and follow-up total symptom scores (TSS) and individual symptom components were assessed, and a 4-hour scintigraphy gastric emptying test (GET) was performed. Hospitalization days, medication use, HbA1c level, and serious adverse events (SAE) were recorded. The median follow-up was 47 months (range 5-90). Mean TSS was significantly reduced from 18.6 to 6.2 points (p ≤ 0.001). GET mean retention of isotope-labeled meal was reduced from 74% to 47% at 2h and from 47% to 19% at 4h (p <0.01). Mean HbA1c improved from 9.0 to 7.9. Annual hospitalization days were reduced from a mean of 25 to 2 (p < 0.05). The overall satisfaction rate was subjectively graded as 87% by the patients. There were no immediate complications; SAEs attributed to GES occurred in 9% of patients. Based on this study, combining GES with pyloroplasty shows long-term: 1) improvement in GP symptoms and a high patient satisfaction rate; 2) acceleration and in some patients' normalization of gastric emptying; 3) a decrease in hospitalizations; and 4) an acceptable safety and SAE profile.