Refractory Diabetic Gastroparesis Research Articles

Wandering Gastric Leads: A Rare Complication of a New Treatment Modality of Gastroparesis

Gastroparesis is a chronic disease characterized by delayed gastric emptying in the absence of mechanical obstruction of the stomach. First-line treatment consists of an antiemetic agent with a pro-motility drug. However, in a 12-year prospective study by Jones et al., they found that symptoms of gastroparesis in diabetic patients often persisted despite adequate glycemic control and optimal medical management. Therefore, the Gastric Electric Stimulator (GES) was made for refractory diabetic gastroparesis, defined by failure of 1 year of medical therapy. [1]. However, despite the benefit of the GES, limited studies are commenting on the potential complications.

S1440 Novel Neuromodulation Treatment Using Repetitive Magnetic Stimulation for Diabetic Gastroparesis: Preliminary Results From a Proof-of-Concept Study

Introduction: Diabetic gastroparesis (DGp) is chartacterized by autonomic neuropathy, for which there are limited effective treatments. Stimulation of thoracic sympathetic and parasympathetic nerves may improve symptoms in patients with diabetic gastroparesis by enhancing gastric contractility. Our aim was to assess safety and feasibility of a novel, non-invasive treatment, Thoracic Splanchnic Magnetic Neuromodulation Therapy (ThorS-MagNT,) for refractory DGp in a proof-of-concept study. Methods: DGp patients, who required hospital admission and without known GI mucosal disease, were included. A mapping procedure in the left and right posterior mid-thoracic regions, using a single-pulse circular 90 mm coil (MAGSTIM, Whitland, UK) determined the location and minimum intensity required to achieve a motor evoked response (MEP) of 10 µV with 50% of trials (resting motor threshold) in the upper rectus abdominis and external oblique muscles. ThorS-MagNT was administered at 50% intensity above motor threshold, using a 70 mm double air film self-cooling coil (MAGSTIM Rapid2) positioned over bilateral pre-determined locations to deliver a total of 1200 stimulations at 1 Hz. Treatments were administered twice daily for five consecutive days. Safety and tolerability data were collected. ANMS GCSI-DD was assessed at baseline and throughout the treatment period. Patients who completed all ten treatments were defined as per protocol. Results: Seven DGp patients (6F; 1M) were enrolled . All subjects tolerated administered treatment sessions. One DGp patient experienced medication-related hypotension-a serious adverse event unrelated to study treatment. After resuscitation and missing one treatment, this subject completed 4 subsequent treatments. One patient reported self-limited tingling and numbness, which resolved after treatment. No other adverse events occurred. In four per protocol subjects, an average of 68.25% reduction in ANMS GCSI-DD score from baseline was observed (Table 1). Two other subjects had an average of 13.95% reduction in ANMS GCSI-DD and one study subject dropped out. Conclusion: ThorS-MagNT appears to be feasible, safe and a promising novel treatment for refractory DGp. Further studies are needed in larger samples to assess its effects on symptoms, hospitalization duration, gastric emptying and safety. Acknowledgement: Supported by the NIDDK Diabetic Complications Consortium grants DK076169 & DK115255.Table 1.: ANMS GCSI-DD scores at baseline versus during treatment.

557-P: Gastric Electrical Neurostimulation Combined with Pyloroplasty for Refractory Diabetic Gastroparesis Improves Subjective and Objective Outcomes

Background: Gastric electrical stimulation (GES) improves symptoms in diabetic gastroparesis (DM GP) refractory to medical therapies but does not increase gastric emptying (GE). This study investigates the clinical outcomes of GES combined with pyloroplasty (PP) to improve GE as well as the pathophysiological characteristics of the responding patients. Methods: Overall 39 DM (13 type I) GP patients with 16.6 (range 3-50) years of DM had GES with PP. Antral and pyloric biopsies were assessed for interstitial cells of Cajal (ICC) status. Depletion of ICC was defined as <10 cells/HPF. GE scintigraphy (normal <60% retention at 2h or <10% at 4 h) was performed, and GP total symptoms score (TTS) of vomiting, nausea, early satiety, bloating, fullness and epigastric pain was assessed with a 5-point Likert scale pre and post-surgery. Results: The 39 patients, (23F) mean age 45 (25-83) years, mean 5.2 years of GP symptoms, were enrolled. TSS improvement after mean follow up of 17 (1-42) months post-surgery was 62% (19.1±3.4) vs.(7.6±6.2), while almost 70% of patients improved TTS by ≥60%. GE at 2h improved from 77% to 45%, and from 55% to 20% at 4h while 47% completely normalized their GE. Both DM1 and DM2 patients responded with improved TSS and GE. Antral ICC were depleted in 28% of DM GP with a mean number of 12 (±5.2)/HPF, while 70% of patients had <10 pyloric ICC with mean 7.4(±5.0)/HPF. Patients with <10 pyloric ICC had a 64% improvement in TSS vs. 41% if pyloric ICC was ≥10/HPF. Conclusion: DM GP patients treated by combining GES and PP show significant symptomatic improvement with accelerated and often normalized GE. Patients with depleted pyloric ICC were the most improved, emphasizing the key role of the pylorus in GP, and explains why adding PP to GES addresses the specific pathophysiological challenges in severe diabetic GP. Disclosure T. Bright: None. I. Sarosiek: None. A. Shanker: None. B.R. Davis: None. O. Padilla: None. J.R. Diaz: None. K. Espino: None. R.M. McCallum: None.

Endoscopic Ultrasonography-Guided Intrapyloric Sphincter Injection of Botulinum Toxin into Muscularis Propria to Treat Refractory Diabetic Gastroparesis

A 46 year-old African American woman with past medical history of diabetes mellitus type 1 for 22 years and gastroparesis for 12 years status post gastric pacemaker placement 2 years ago presented with abdominal pain, nausea, and recurrent vomiting for 2 days. The severity of her symptoms on the day of admission, as measured by the gastrointestinal symptom rating scale (GSRS), was 16. Due to the refractory nature of her symptoms, EUS-guided intrapyloric injection of botulinum toxin was performed. 100 units of botulinum toxin was diluted with normal saline to 25 U/ml and injected into 4 quadrants of muscularis propria of pyloric sphincter, with a 25-gauge FNA needle (Figure 1). On post procedure day one the patient demonstrated significant improvement in her symptoms and scored 11 on the GSRS. She was discharged from the hospital soon after. During follow up 3 weeks post procedure, she reported one episode of vomiting since being discharged and scored 8 on the GSRS. She was again seen on post procedure week 4 and reported only intermittent nausea with no further episodes of vomiting. Her GSRS score at 4 and 12 weeks post procedure were 5 and 4, respectively. Diabetic gastroparesis is a relatively common and often difficult to manage chronic motility disorder where there is delayed gastric emptying in the absence of mechanical obstruction. It is thought to arise from a complex interplay of factors including disturbances in fundic accommodation, gastric arrhythmia, impaired corpus-antral contractility, vagal neuropathy and pyloric dysfunction (in the form of pylorospasm). Symptoms include nausea, vomiting, early satiety and epigastric pain. The currently available modalities of treatment for this condition, including prokinetic medications and placement of gastric pacemaker, are often sub-optimally efficacious. Based on the theory that gastric emptying improves with decreased pyloric resting pressure, intrapyloric sphincter botulinum toxin injection was introduced in 1998. Since that time, its use has been reported to have variable clinical response in the medical literature. We postulate that inconsistencies in clinical response from botulinum toxin injection may be due, in part, to variability in injection sites, and propose that its efficacy may be improved by precise injection (via EUS guidance) into the muscularis propria of pyloric sphincter, as was demonstrated in our case. Further clinical studies in patients with are required to confirm our hypothesis.Figure: Linear array endoscopic ultrasonography-guided botulinum toxin injection by a 25-gauge needle (large arrow) into the muscularis propria (small arrow) of pylorus in a patient with refractory diabetic gastroparesis.

Treatment of refractory diabetic gastroparesis: Western medicine and traditional Chinese medicine therapies.

Refractory diabetic gastroparesis (DGP), a disorder that occurs in both type 1 and type 2 diabetics, is associated with severe symptoms, such as nausea and vomiting, and results in an economic burden on the health care system. In this article, the basic characteristics of refractory DGP are reviewed, followed by a discussion of therapeutic modalities, which encompasses the definitions and clinical manifestations, pathogenesis, diagnosis, and therapeutic efficacy evaluation of refractory DGP. The diagnostic standards assumed in this study are those set forth in the published literature due to the absence of recognized diagnosis criteria that have been assessed by an international organization. The therapeutic modalities for refractory DGP are as follows: drug therapy, nutritional support, gastric electrical stimulation, pyloric botulinum toxin injection, endoscopic or surgical therapy, and traditional Chinese treatment. The therapeutic modalities may be used alone or in combination. The use of traditional Chinese treatments is prevalent in China. The effectiveness of these therapies appears to be supported by preliminary evidence and clinical experience, although the mechanisms that underlie these effects will require further research. The purpose of this article is to explore the potential of combined Western and traditional Chinese medicine treatment methods for improved patient outcomes in refractory DGP.

Combination of symptoms, syndrome and disease: treatment of refractory diabetic gastroparesis.

To assess effect of combination of symptoms, syndrome and disease on treatment of diabetic gastroparesis with severe nausea and vomiting. Professor Tong Xiaolin's clinical electronic medical records of patients who were treated between January 1, 2006 and October 1, 2012 were used as a database. Patients who met the inclusion criteria were enrolled. General information (name, sex and age), symptoms and blood glucose levels were obtained from the clinic electronic medical record, which was supplemented by a telephone interview. The patient-rated Gastroparesis Cardinal Symptom Index (GCSI) was used to evaluate the severity of the symptoms of gastroparesis. The effects of the treatment were assessed by the change in the severity of the symptoms of gastroparesis and the change in blood glucose between the baseline levels and the post-treatment levels at 1, 2, 4, 8 and 12 wk. Forty-five patients had a mean GCSI nausea and vomiting severity score of 4.21 ± 0.67 and a total GCSI score of 2.77 ± 0.63 before treatment. There was a significant improvement in the nausea and vomiting score at every return visit compared with the baseline score (1 wk: 3.02 ± 1.04 vs 4.18 ± 0.71, P < 0.001; 2 wk: 2.32 ± 1.25 vs 4.16 ± 0.73, P < 0.001; 4 wk: 2.12 ± 1.26 vs 4.12 ± 0.73, P < 0.001; 8 wk: 1.79 ± 1.09 vs 4.24 ± 0.77, P < 0.001; 12 wk: 0.69 ± 0.92 vs 4.25 ± 0.70, P < 0.001). Twenty-five of the 45 patients had complete resolution of vomiting during the observation period (mean time to resolution was 37.9 ± 27.3 d). The postprandial fullness and early satiety subscale, bloating subscale and total GCSI scores were also improved. Finally, the blood glucose levels improved after treatment, although the change was not significant. Use of the combination of symptoms, syndrome and disease to treat diabetic gastroparesis with refractory nausea and vomiting may be a new treatment option.

Laparoscopic longitudinal gastrectomy and duodenojejunostomy for treatment of diabetic gastroparesis

i g t t b Gastroparesis is a chronic motility disorder of the stomach characterized by delayed gastric emptying in the absence of mechanical obstruction [1]. Severe gastroparesis that is refractory to medical management results in malnutrition and recurrent hospitalizations. No consensus has been reached regarding the treatment of patients with gastroparesis that failed medical therapy [1]. Randomized controlled trials of intrapyloric botulinum toxin injection [2] and gastric electrical stimulation [3] have failed to improve he rate of gastric emptying or associated symptoms. Traitional surgical approaches, including completion or subotal gastrectomy, have been poorly studied [4]. Sleeve gastrectomy performed for morbid obesity is asociated with increased gastric emptying [5]. This proceure removes the greater curvature of the stomach, leaving residual gastric tube based on the lesser curvature blood upply. The mechanism by which sleeve gastrectomy inreases gastric emptying is not known. However, this mechnism might be therapeutic if reproduced in a diabetic astroparesis case. We present a case in which laparoscopic longitudinal gasrectomy and duodenojejunostomy were successful for the reatment of refractory diabetic gastroparesis and diabetes.

Pharmacotherapy for Gastroparesis: An Attempt to Evaluate a Safer Alternative

Pharmacotherapy for Gastroparesis: An Attempt to Evaluate a Safer Alternative

Gastric Electrical Stimulation With Enterra Therapy Improves Symptoms From Diabetic Gastroparesis in a Prospective Study

Gastric electrical stimulation (GES) treats refractory gastroparesis by delivering electric current, via electrodes, to gastric smooth muscle. Enterra therapy (Medtronic, Inc, Minneapolis, MN) uses an implantable neurostimulator with a high-frequency, low-energy output. We performed a controlled, multicenter, prospective study to evaluate the safety and efficacy of Enterra therapy in patients with chronic intractable nausea and vomiting from diabetic gastroparesis (DGP). Patients with refractory DGP (n = 55; mean age, 38 y; 66% female, 5.9 years of DGP) were given implants of the Enterra gastric stimulation system. After surgery, all patients had the stimulator turned on for 6 weeks and then they randomly were assigned to groups that had consecutive 3-month, cross-over periods with the device on or off. After this period, the device was turned on in all patients and they were followed up, unblinded, for 4.5 months. The median reduction in weekly vomiting frequency (WVF) at 6 weeks, compared with baseline, was 57% (P < .001). There was no difference in WVF between patients who had the device turned on or off during the cross-over period (median reduction, 0%; P = .215). At 1 year, the WVF of all patients was significantly lower than baseline values (median reduction, 67.8%; P < .001). Patients also had significant improvements in total symptom score, gastric emptying, quality of life, and median days in the hospital. In patients with intractable DGP, 6 weeks of GES therapy with Enterra significantly reduced vomiting and gastroparetic symptoms. Patients had improvements in subjective and objective parameters with chronic stimulation after 12 months of GES, compared with baseline.

Correction: A case of severe, refractory diabetic gastroparesis managed by prolonged use of aprepitant

Chong, K. & Dhatariya, K. A case of severe, refractory diabetic gastroparesis managed by prolonged use of aprepitant. Nat. Rev. Endocrinol. 5, 285–288 (2009). In the May issue of Nature Reviews Endocrinology, the dosage of erythromycin in the first sentence of the fourth paragraph of The Case section should have read “low-dose erythromycin (0.

A case of severe, refractory diabetic gastroparesis managed by prolonged use of aprepitant

A 31-year-old woman with an 11-year history of poorly controlled type 1 diabetes mellitus was admitted with severe vomiting and ketoacidosis. The patient had been admitted to hospital on 14 occasions in the past 3 years for diabetic ketoacidosis precipitated by intractable vomiting, and she had been diagnosed with gastroparesis 2 years previously. Assessment of the patient's response to standard treatments for diabetic gastroparesis. These approaches involved tight glycemic control that included subcutaneous insulin infusion via a pump, correction of electrolyte disturbances, use of standard antiemetic and promotility agents, somatostatin-analog treatment, intrapyloric injection of botulinum toxin, and insertion of a percutaneous jejunal feeding tube. Severe diabetic gastroparesis refractory to standard treatments. The neurokinin-receptor antagonist aprepitant was started and her vomiting stopped within 24 h. This treatment was successfully continued for 4 months until a gastric electrical stimulation device was inserted, which enabled aprepitant treatment to be withdrawn and the percutaneous jejunostomy feeding tube to be removed. This successful treatment led to a substantial improvement in the patient's quality of life and overall glycemic control.

Visceral hypersensitivity and impaired accommodation in refractory diabetic gastroparesis

The pathophysiology of persistent gastrointestinal (GI) symptoms in patients with diabetic gastroparesis is poorly understood. Our aim was to evaluate gastric sensation and accommodation to a meal in patients with diabetic gastroparesis and refractory symptoms. We performed intermittent, phasic balloon distensions of the stomach using a gastric barostat device in 18 patients with diabetes and gastroparesis unresponsive to prokinetic therapy and in 13 healthy volunteers. We assessed the biomechanical, sensory and accommodation responses of the stomach, during fasting and after liquid meal. During balloon distension, the sensory thresholds for discomfort were lower (P < 0.02) in patients with diabetes than those in controls, in both the fasting and the postprandial states. The accommodation response to a meal was significantly impaired (P = 0.01) in patients with diabetes when compared to controls, although fasting gastric tone was similar (P = 0.08). Patients with diabetic gastroparesis and refractory GI symptoms demonstrate sensori-motor dysfunction of the stomach, comprising either impaired accommodation, gastric hypersensitivity or both. An objective evaluation of these biomechanical and sensory properties may provide valuable mechanistic insights that could guide therapy.

43 Gastric Electrical Stimulation in Severe Gastroparesis – The Scottish Experience

Introduction: Gastroparesis (GP) is a common complication of type 1 and 2 diabetes affecting up to 50% of the diabetic population. In severe cases diabetic gastroparesis (DGP) may be profoundly disabling with severe GI symptoms, prolonged hospital stay and potentially life‐threatening metabolic upset. Standard management of DGP with dietary changes or drug treatment is unsatisfactory in many patients. The development of gastric electrical stimulation (GES) in drug refractory DGP has been shown to be beneficial in this difficult group of patients. In Scotland GES has only recently been available as a treatment option and we report here our initial experience in both diabetic and idiopathic gastroparesis patients. We have treated 7 patients (5 female), age 30 (21–73) (median, range) over a 3 years period. Of the 7 patients 5 were type 1 diabetics and 2 had idiopathic gastroparesis. All had severe drug refractory GP and 6/7 had required enteral feeding prior to GES implantation. All 7 patients had GES initiated with the Enterra (Medtronic) neural stimulator placed at mini‐laparotomy. No peri‐operative complications were noted. One patient died of unrelated sepsis 6 month post‐implant. GES was initiated with standard parameters (frequency 14 Hz, intensity 5 mA, pulse width 330 μs; cycle on 0.1 s; cycle off 5 s).All 6 patients who had required enteral feeding pre‐GES had their feeding tubes removed at surgery and have had normal nutritional intake without supplemental feeding after GES [follow‐up 24 month (11–34)].Gastric emptying as assessed by dual phase solid/liquid labeled meals improved in 50% of our patients.Conclusions: GES significantly improves the weekly vomiting frequency in patients with GP and avoids the need for enteral feeding. Long‐term GES should be considered as a treatment option in all drug refractory GP patients. Results (6 months) PRE POST GES Median (range) Weekly vomiting frequency 25 (15–35) 4 (1–6) *p &lt; 0.001 Weight (kg) 49 (44–70) 54 (50–89) p = ns

Does combination prokinetic therapy benefit patients with refractory diabetic gastroparesis?

Does combination prokinetic therapy benefit patients with refractory diabetic gastroparesis?

Severe refractory diabetic gastroparesis. What is the utility of jejunostomy tube placement? A long-term retrospective review of the 26 patients: [formula omitted], J.L. Barnett. Dept of Internal Medicine, University of Michigan, Ann Arbor, MI

Severe refractory diabetic gastroparesis. What is the utility of jejunostomy tube placement? A long-term retrospective review of the 26 patients: [formula omitted], J.L. Barnett. Dept of Internal Medicine, University of Michigan, Ann Arbor, MI