Key clinical point: An implanted gastric electrical stimulation device significantly improved refractory vomiting but did not improve quality of life in patients with and without gastroparesis.
Major finding: At 4 months, vomiting improved significantly among patients with either delayed (P less than .01) or normal (P = .05) baseline gastric emptying times.
Study details: Multicenter, randomized, double-blind trial of 179 patients; after the initial assessment, 149 patients crossed over to the other arm.
Disclosures: The French government funded the study. The investigators reported having no conflicts of interest.
Ducrotté P et al. Gastroenterology. 2019 Oct 1. doi: 10.1016/S0016-5085(17)30875-2.
Use of gastric electric stimulation is a controversial therapy for gastroparesis. The Enterra Gastric Electric Stimulator System received FDA approval under a Humanitarian Device Exemption in 2000 considering the device to be safe and of probable benefit. Enterra had been shown to decrease vomiting frequency in patients with medication refractory gastroparesis. Subsequent studies performed for approval for efficacy did not meet their predefined endpoint. Some physicians use this as treatment for their patients with refractory gastroparesis under the HDE and with institutional review board approval; many physicians do not.
The article by the French group brings support for gastric electric stimulation in a double blind study that showed gastric stimulation significantly reduced nausea and vomiting, both in diabetic and nondiabetic patients and in both those with delayed and normal gastric emptying.
The NIH Gastroparesis Clinical Research Consortium recently reported the symptom response with gastric stimulation for clinical care of patients with gastroparesis, compared with those who did not receive this treatment. In this observational study in multiple practice settings, 15% of patients with symptoms of gastroparesis in the NIH registry underwent gastric stimulation. Patients with more severe overall symptoms were more likely to improve symptomatically over 48 weeks, primarily because of reduction in nausea severity.
In the last 5 years, pyloromyotomy for gastroparesis has reemerged as a treatment for gastroparesis, especially when performed endoscopically (G-POEM or POP). Multiple studies, primarily single-center studies, support this treatment in improving gastroparesis symptoms and gastric emptying, though placebo-controlled studies have not been performed.
When should one perform gastric electric stimulation versus pyloromyotomy? At our center, we perform both stimulator placement and pyloromyotomy procedures in patients with refractory gastroparesis symptoms with delayed gastric emptying. We find that patients with refractory symptoms of gastroparesis undergoing stimulator placement, pyloromyotomy, or combined stimulator with pyloromyotomy each had improvement of their gastroparesis symptoms. Gastric stimulation and combined stimulator with pyloromyotomy improved nausea/vomiting, whereas pyloromyotomy alone tended to improve early satiety and postprandial fullness.
Presently, our clinical protocol for patients with refractory gastroparesis (not responding to metoclopramide, domperidone, granisetron patch, mirtazapine) is the following:
- If nausea and vomiting are particularly severe, we proceed with gastric stimulation.
- If gastric emptying is significantly delayed especially with symptoms of early satiety, patients undergo pyloromyotomy.
- If patients have significant nausea and vomiting with markedly delayed gastric emptying, patients get both stimulator placement and pyloromyotomy.
Studies are currently being performed to evaluate this type of patient-oriented management approach.
Henry P. Parkman, MD, gastroenterologist, gastroenterology section, Temple University, Philadelphia. He has no conflicts of interest.