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Selecting the Right Patient for Gastric Electrical Stimulation: Using Blinded Temporary Stimulation Trials in
Andrea Geleni Gongora1, Christel Gharby1, Madison Wnuk1
1Department of Surgery, University of Florida College of Medicine, Gainesville, FL, USA.
Summary
Blinded trials for temporary gastric stimulation (tGES) in children with gastroparesis (GP) improved patient selection. This method identified patients with consistent symptom relief, leading to lower implant rates and fewer early device failures.
Area of Science:
- Pediatric Gastroenterology
- Medical Device Technology
- Clinical Trial Design
Background:
- Gastric electrical stimulation (GES) is used for pediatric gastroparesis (GP).
- Temporary GES (tGES) trials guide permanent implant selection.
- Non-responders and early failures necessitate improved patient selection methods.
Purpose of the Study:
- To evaluate the efficacy of blinded tGES trials for patient selection in pediatric GP.
- To compare outcomes between blinded and non-blinded tGES trials.
- To assess the impact of blinded trials on permanent implant rates and early device failures.
Main Methods:
- A cohort study of 4-26 year olds undergoing blinded (B) or non-blinded (NB) tGES for GP.
- Patients in the B group crossed over between ON and OFF stimulation.
- Outcomes measured included Gastroparesis Cardinal Symptom Index (GCSI), nutritional intake, and implant success.
Main Results:
- Of 84 patients, 57 were NB and 27 B.
- NB group: 96.5% improved GCSI, 86% implanted.
- B group: 51.9% showed concordant response (improved ON, worsened OFF), 44.4% implanted. One early failure in B vs. nine in NB.
Conclusions:
- GES is effective for severe pediatric and adolescent GP.
- Blinded tGES trials improve patient selection for permanent implantation.
- Blinded trials correlate with lower implant rates and reduced early failures, warranting further study on long-term outcomes.
