Combined Gastric Electrical Stimulation and Pyloroplasty in Gastroparesis: A Randomized Clinical Trial.

Importance: Patients with gastroparesis who do not respond to medical therapy may require surgical intervention, typically involving pyloroplasty (PP) alone or with implantation of a gastric electrical stimulation (GES) device. Objective: To investigate the outcomes of combining PP with GES in medication-refractory gastroparesis. Design, Setting, and Participants: This double-blind randomized clinical trial included patients who had diabetic or idiopathic gastroparesis. Patients from a US academic gastrointestinal motility clinic, who failed medical therapy, were included from January 10, 2017, to September 20, 2023. Patients were followed up for 6 months. Interventions: Patients with refractory gastroparesis underwent simultaneous implantation of GES with PP and were randomized into PP + GES-ON and PP + GES-OFF groups. In the PP + GES-ON group, the GES was turned on after surgery. In the PP + GES-OFF group, the device was kept off for 3 months and then was turned on for the following 3 months. Main Outcomes and Measures: Symptom scores measured with the Gastroparesis Cardinal Symptom Index (GCSI) and the total symptom score (TSS), gastric emptying, and hospitalization length of stay were recorded and compared at baseline and at 3-month and 6-month follow-up visits. Between-group comparisons at 3 months were performed using the Wilcoxon rank sum test following the intention-to-treat procedure. Results: The study included 38 patients with gastroparesis (24 females [63.2%]; mean [SD] age, 46.7 [13.2] years), of whom 31 (81.6%) had diabetic gastroparesis, and 7 (18.4%) had idiopathic gastroparesis. Patients were randomized to the PP + GES-ON (n = 19) or the PP + GES-OFF (n = 19) group. At 3 months, the improvement from baseline in the GCSI (median [IQR] ON: -2.2 [-2.6 to -1.5] vs median [IQR] OFF: -0.9 [-1.8 to -0.4]; median difference, -1.33 [95% CI, -2.34 to -0.33]; P = .01) and the TSS (median [IQR] ON: -15.0 [-16.0 to -8.0] vs median [IQR] OFF: -3.0 [-10.0 to -1.0]; median difference, -12.00 [95% CI, -17.49 to -6.51]; P = .005) was significantly greater in the PP + GES-ON compared with the PP + GES-OFF group. Both groups exhibited significantly faster and similar gastric emptying results compared with the baseline. When the PP + GES-OFF group had GES activated at 3 months, symptoms improved significantly by 6 months (median [IQR] GCSI at 6 months: 1.2 [0.4-2.5] vs at baseline: 3.3 [2.8-4.1]; median [IQR] TSS at 6 months: 8.0 [2.0-10.0] vs at baseline: 18 [14.0-21.0]), achieving results comparable with those patients who had their GES device on for the full 6 months. These results at 6 months were accompanied by a significant reduction in hospital length of stay (median [IQR] at 6 months: 0 [0-2.0] vs at baseline: 4.1 [0-10.1]) and an excellent safety profile. Conclusions and Relevance: In this randomized clinical trial, the combination of GES and PP yielded superior outcomes compared with PP alone, resulting in greater alleviation of gastroparesis symptoms and a reduction in hospitalization, which may enhance patient profiling and optimize decision-making for treatments. Trial Registration: ClinicalTrials.gov Identifier: NCT03123809.