Efficacy and Safety of Gastric Electrical Stimulation in Refractory Diabetic Gastroparesis
Abstract Number: 0005-OR
Authors: KYPARISSI KARATZIDOU, CAROLINE BOURGEOIS, LAURENT BRESLER, NAD[Egrave]GE LAGUERRE, OLIVIER ZIEGLER, BRUNO GUERCI, CHU of NANCY, France
Results: Aims: We aimed to investigate the efficacy and safety of high-frequency gastric electrical stimulation (GES), as treatment of diabetic gastroparesis.
Methods: Nine type 1 diabetic patients (4 M, 5 F, age: 46±8yrs, duration of diabetes: 28±7yrs) underwent a laparoscopic implantation of electrical stimulation device (Enterra Therapy, Medtronic, USA). Inclusion criteria were: medically refractory gastroparesis documented by gastric emptying scintigraphy (retention>60% at 2h and/ or >10% at 4h), associated with severe upper gastrointestinal symptoms, poor metabolic control (HbA1c>8%) and/or glycemic instability characterized by recurrent or severe hypoglycemic episodes. Gastric emptying scintigraphy, continuous interstitial glucose (IG) measurements by CGMS®, HbA1c and gastrointestinal (GI) symptoms and SF-36 quality of life questionnaires, were obtained before intervention (M0) and at 3 (M3) and 6 (M6) months after implantation.
Results: HbA1c was significantly reduced in all patients (10.3±0.9%, 8.9±0.9%, 8.3±0.9% at M0, M3 and M6, p=0.01). CGMS recordings showed a tendency towards reduction in duration of hypoglycemic events (IG <72mg/dl) (M0-6 331±266 vs. 187±165 min/72h, p=0.24). No severe hypoglycemic episode was reported at follow-up. Standard deviation of IG as measure of glucose variability slightly improved (M0-6: 79.8±23.4 vs 66.8±11.4 mg/dl). An improvement was noticed in nausea (3.4±4.4 vs 0.5±1.2 h/day, p=0.04) and bloating score (2.2±0.7 vs 0.5±0.8, p=0.03) at M0-6. Nevertheless this improvement in GI symptoms was not followed by a significant improvement at scintigraphy (M02h vs. M62h: 80±16% vs. 72±24%, M04h vs. M64h: 58±29% vs. 48±28%). A tendency for improvement was also noticed in SF-36 scores. In one patient the GES system was removed due to pocket infection six weeks after implantation.Conclusions: In diabetic patients with medically refractory gastroparesis, high-frequency GES significantly improved glycemic control and upper GI symptoms. Differences towards improvement were also found in quality of life and hypoglycemia. A further evaluation at 12 months and at long term is needed to confirm these preliminary results.