This randomized controlled trial included 38 participants with either diabetic or idiopathic gastroparesis who were unresponsive to medical therapy at an academic center for gastrointestinal motility disorders within the United States from January 10, 2017, and continues to today, with completion set on or before September 20, 2023. Within this group, there were 24 females (63.2%) with an average SD age of 46.7 years. The majority, 81.6%, were unresponsive due to diabetic gastroparesis, and 18.4% were unresponsive due to idiopathic gastroparesis. Participants were evenly randomized into either PP+GES-ON or PP+GES
All participants underwent pyloroplasty and GES device implantation. For participants in PP + GES-ON, the GES device was turned on immediately after surgery. Participants with PP + GES-OFF had no GES device use for 3 months and then active for 3 months. Analysis on GCSI and TSS scales took place at zero months, 3 months, and 6 months. Gastric emptying rates and duration of hospital stay were also measured.
Key Findings
At 3 months, the PP + GES-ON group showed greater improvement compared with PP + GES-OFF:
• GCSI: median change −2.2 (IQR −2.6 to −1.5) vs −0.9 (IQR −1.8 to −0.4); median difference −1.33 [95% CI, −2.34 to −0.33]; P = .01
• TSS: median change −15.0 (IQR −16.0 to −8.0) vs −3.0 (IQR −10.0 to −1.0); median difference −12.0 [95% CI, −17.49 to −6.51]; P = .005
When GES was activated in the PP + GES-OFF group at 3 months, symptom scores improved by 6 months, achieving similar results as the PP + GES-ON group:
• GCSI at 6 months: 1.2 (IQR 0.4–2.5) vs baseline 3.3 (2.8–4.1)
• TSS at 6 months: 8.0 (IQR 2.0–10.0) vs baseline 18.0 (14.0–21.0)
• Hospitalization length was significantly reduced at 6 months (median 0 days [IQR 0–2] vs baseline 4.1 days [IQR 0–10.1]).
• The safety profile was excellent, with no serious adverse events reported during follow-up.
Within the randomized controlled trial, there were more benefits associated with a combination of pyloroplasty and gastric electrical stimulation compared with pyloroplasty alone, indicating alleviation of gastroparesis and reduced hospital admissions. The intervention underscores the importance of addressing gastroparesis from multiple approaches.
Reference:
Sarosiek I, Bashashati M, Davis BR, et al. Combined Gastric Electrical Stimulation and Pyloroplasty in Gastroparesis: A Randomized Clinical Trial. JAMA Netw Open. 2025;8(12):e2546332. doi:10.1001/jamanetworkopen.2025.46332
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