Introduction Severe, drug-unresponsive gastroparesis is a debilitating condition. Treatment with gastric electrical stimulation using Enterra® was granted humanitarian device exemption status by the FDA in 2000. The largest case-series (N=221) reports that 54% of patients had >50% symptom-reduction with Enterra.1 We audited outcomes from Enterra therapy, with routine use of a trial of temporary stimulation to refine patient selection.
Methods Patients considered for Enterra during 2008–2011 were identified from a prospectively maintained database. Patients had been previously extensively investigated and treated for gastroparesis; 48% were referred by gastroenterologists and 37% by upper GI surgeons. Gastric emptying was assessed by scintigraphy in all cases. Candidates for Enterra had a 2-week trial of temporary stimulation, via a trans-nasal electrode that was endoscopically implanted into the gastric submucosa. Only those with good response proceeded to laparoscopic implantation of a permanent Enterra device. 50% or greater symptom-reduction was classified as a good response.
Results There were 71 patients (51 women, 72%), with median age 42 years (range, 14–69). The aetiology of gastroparesis was idiopathic (43 patients, 61%), diabetes (15, 21%) or post-surgical (13, 18%). At presentation, oral nutrition was supplemented by naso-jejunal tube feeding in seven patients, surgical jejunostomy in eight or parenterally in one (total, 16 patients; 22%). Previous intervention included endoscopic injection of Botulinum toxin (Botox) into the pylorus in 16 patients (22%), pyloroplasty in two, distal gastrectomy in one and gastrojejunostomy in one. It was decided to directly proceed with permanent Enterra in four patients. Of the remaining, 51 patients have currently completed a trial of temporary stimulation; 39 (77%) had a good response and were selected for permanent Enterrra, which has been completed in 35 patients. Outcome data are currently available for 31 patients (idiopathic, 21 patients; diabetes, three; post-surgical, seven), with median follow-up period of 10 months (1–28). 22 patients (71%) had a good response to permanent Enterra; these included 14 (68%) with idiopathic, 5 (71%) with post-surgical and all three with diabetic gastroparesis.
Conclusion 71% of well-selected patients with intractable gastroparesis had good response to permanent gastric electrical stimulation with Enterra at follow-up up to 2 years. These data compare advantageously with reported data (>50% symptom-reduction in 54%)1 and support the inclusion of a trial of temporary stimulation in the selection algorithm for permanent Enterra therapy.
Competing interests None declared.
Reference 1. McCallum, et al. Gastric electrical stimulation improves outcomes of patients with gastroparesis for up to 10 years. Clin Gastroenterol Hepatol 2011;9:314–19.
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