Gastric Neurostimulation Research Articles

Addition of pyloroplasty may improve glycemic control and refractory early satiety in gastroparesis at rates similar to gastric neurostimulation alone: a retrospective analysis

Objectives Gastroparesis that is refractory to standard dietary and medical management may benefit from surgical treatment with gastric electrical neurostimulation, which has shown promise in reducing symptoms of the disease. Pyloroplasty may serve an adjunctive role to a gastric stimulator, but the precise benefit remains unclear. The present study compares reported rates of symptom improvement following gastric neurostimulator implantation with and without pyloroplasty. Materials and methods A single center retrospective analysis of consecutive patients who received operative management for symptom refractory gastroparesis from 1 January 2020 to 31 December 2021 was performed. Subjects were assigned to cohorts based on treatment with gastric electrical stimulation alone (GES-only) or combined with pyloroplasty (GES + PP). A survey-based assessment was administered post-operatively that evaluated cardinal symptoms of gastroparesis (nausea, vomiting, early satiety) before and after treatment. Results In total, 42 patients (15 GES-only, 27 GES + PP) were included in the study. Both groups reported a high degree of improvement in global symptom control following surgery (93% vs 81%) with no differences between treatment cohorts (p = 0.09). Early satiety demonstrated better improvement in patients who received gastric stimulation alone (p = 0.012). Subgroup analysis of diabetic gastroparesis patients showed a 2.2% decrease in hemoglobin A1c levels in the GES + PP group (p-0.034). Conclusions Symptom reduction in refractory gastroparesis appears to improve after placement of a gastric neurostimulator with or without the addition of a pyloroplasty procedure.

Optimal Parameters for Gastric Electrical Stimulation Therapy for Long-Term Symptom Control in Patients with Gastroparesis

Background: Gastric electrical stimulation (GES) therapy is indicated for the treatment of drug-refractory gastroparesis (GP). However, the long-term effects of GES therapy on GP symptom control and identification of the optimal parameters to activate this long-term efficacy have not been investigated. Methods: We conducted a retrospective cohort analysis of 57 GP patients who received GES and pyloroplasty (PP). The interrogation of the GES system and assessment of GP symptoms were conducted at the initiation of GES therapy and during follow-up visits. We determined the changes in GES parameters including voltage (V), impedance (I), and current (C). The outcome was total symptom score (TSS), which was measured by self-reported GP symptoms. Results: The mean age of patients was 44 (±14) years, and 72% were females. The etiology for GP was diabetes mellitus in 72% and idiopathic in 28%. The median duration of GES follow-up was 47 months (range 5–73) A significant decrease was found in individual symptom scores and the TSS (−10.8; 95%CI: −12.6, −9.08) compared to baseline scores (p < 0.0001). During follow-up, readings for I (515 vs. 598 Ω), V (3.3 vs. 4.8 V), and C (6.5 vs. 8.4 mA) significantly increased (p ≤ 0.0001 for all parameters). Higher GES settings were associated with lower TSS in the adjusted analysis (RC, −1.97; 95%CI: −3.81, −0.12, p = 0.037). Conclusions: these findings suggest that adjusting GES parameters over time based on optimizing symptom improvement should be incorporated into the long-term care of patients receiving gastric neurostimulation therapy.

Reoperation after gastric neurostimulation device placement: A descriptive study

Reoperation after gastric neurostimulation device placement: A descriptive study

Health services utilization of patients with gastroparesis treated with gastric neurostimulation with and without concomitant pyloroplasty or subsequent pyloromyotomy

Health services utilization of patients with gastroparesis treated with gastric neurostimulation with and without concomitant pyloroplasty or subsequent pyloromyotomy

Gastric peroral endoscopic myotomy for management of refractory gastroparesis in patients with gastric neurostimulator devices: a multicenter retrospective case control study

Gastric neurostimulation (GNS) and gastric peroral myotomy (G-POEM), therapies for refractory gastroparesis, are associated with suboptimal outcomes. We studied the role of G-POEM as a salvage therapy in patients with refractory symptoms after GNS implantation. This was a multicenter, retrospective, matched-case control study. Consecutive patients with GNS device and underwent G-POEM as a salvage therapy for clinical failure (cases) and patients without GNS implantation and underwent G-POEM for refractory gastroparesis (control) between 10-2018 and 08-2021 were included. The primary outcome was clinical success after G-POEM. A total of 123 patients (mean age 45.7 ± 14.7 years; 88 females [72%]) underwent G-POEM therapy during the duration of the study: 41 cases and 82 controls. Clinical success was achieved in 66% in the case group and 65% in the control, (P=0.311), during a median total clinical follow-up time of 11.8 (IQR: 2.4-6.3) months. In the case group, the mean Gastroparesis Cardinal Symptom Index (GCSI) decreased from 2.8 ± 1.8 to 1.5 ± 1.9, (P=0.024), and gastric retention at 4 hours improved from 45% ± 25.8 to 16.6% ± 13.1, (P=0.06). The mean delta improvement in the subscales of nausea/vomiting (1.3 ± 0.6 vs. 0.9 ± 1.1; P=0.044) and bloating (1.6 ± 1.3 vs. 1.2 ± 1.4; P=0.041) were significantly higher in cases than in controls. Among patients with refractory symptoms after GNS, G-POEM can be a reasonable salvage therapy to provide further symptomatic relief with evidence of a potential additive effect of both G-POEM and GNS.

Placement of Gastric Neurostimulator Results in Reduced Symptoms and Rates of Hospitalization in Patients with Medically-Refractory Gastroparesis

Journal of the American College of Surgeons 236(5):p S3-S4, May 2023. | DOI: 10.1097/01.XCS.0000932252.73541.b3

Medical Service Use of Gastroparesis Patients Treated with Gastric Neurostimulation with or without Pyloroplasty or Pyloromyotomy

Bernardi, Karla MD; Davis, Graham MD; Allen, William BS; Saad, Adham R. MD, FACS; Velanovich, Vic MD, FACS Author Information

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.

Patient factors influence surgical options in gastroparesis

BackgroundPatient selection for the diverse surgical procedures for gastroparesis remains poorly defined. Our aim was to evaluate how patient factors have determined our surgical approach to gastroparesis. Methods95 patients undergoing 105 surgical procedures for gastroparesis were reviewed. Patient factors were compared across six surgical procedures: gastric neurostimulator, pyloroplasty, neurostimulator plus pyloroplasty, sleeve gastrectomy, gastric bypass and gastrectomy. Global symptom severity was determined preoperatively and at last follow up. ResultsThere were significant differences in etiology, BMI and gastroesophageal reflux across the various operations. Patients undergoing pyloroplasty and gastrectomy; were more likely to have a postsurgical etiology. (p < .05) Patients undergoing sleeve gastrectomy and gastric bypass were more likely to have BMI >35. (p <.05) Those undergoing sleeve gastrectomy were less likely to have gastroesophageal reflux preoperatively. (p <.05) There was no difference in preoperative clinical stage across the procedures. ConclusionPatient factors influence choice of procedure in the surgical treatment of gastroparesis. Etiology of gastroparesis, BMI >35 and gastroesophageal reflux are important determinants.

Childhood gastroparesis is a unique entity in need of further investigation.

Despite increasing knowledge regarding gastroparesis (GP) in adults, little is known regarding the incidence, prevalence, and natural history of childhood GP. Exacerbating the knowledge gap in pediatric GP is both the lack of normative data for gastric emptying scintigraphy in children and lack of GP-specific pediatric reported outcome measures. The aim of this article was to review the available literature on pediatric GP and identify similarities and differences with studies in adults. We performed a comprehensive search in MEDLINE and Google Scholar from inception to April 2019 for articles published in English using the following combination of keywords: gastroparesis, pediatric gastroparesis, outcomes, metoclopramide, erythromycin, domperidone, cisapride, and gastric neurostimulator. The limited available pediatric data, often retrospective, suggest marked differences between adult and pediatric GP in several aspects including etiology, concomitant co-morbidities (eg, psychiatric disorders), clinical symptom presentation, diagnostic evaluation, response to therapies, and clinical outcome. Further research in pediatric GP is needed and holds the promise to further elucidate the mechanisms of this disorder in children and lead to pediatric-focused therapies.

Mo1574 – Gastric Electrical Neurostimulation Combined with Pyloroplasty is the Final Solution for Refractory Gastroparesis Based on Subjective and Objective Longterm Outcomes

Mo1574 – Gastric Electrical Neurostimulation Combined with Pyloroplasty is the Final Solution for Refractory Gastroparesis Based on Subjective and Objective Longterm Outcomes

RA01.08: LAPAROSCOPIC ROUX-EN-Y GASTROJEJUNOSTOMY FOR GASTRIC CONDUIT OUTLET OBSTRUCTION FOLLOWING ESOPHAGECTOMY FOR CANCER

Abstract Description After Ivor Lewis esophagectomy, gastric outlet obstruction refractory to prokinetic therapy and/or endoscopic pyloric dilatation is a challenging clinical problem. Thoracoscopic implant of a gastric neurostimulator has been reported to be effective, but long-term results are lacking. The patient, a 57-year-old woman, underwent a Ivor Lewis esophagectomy for T1N0 adenocarcinoma in 2007. Postoperatively, the patient complained of persistent dysphagia, regurgitation, and 29-kg weight loss. A mechanical obstruction was ruled out by barium swallow study and upper gastrointestinal endoscopy. Several conservative attempts with prokinetic agents and endoscopic dilatations failed, and the patient was exclusively fed through jejunostomy until the thoracoscopic implant of a gastric neurostimulator in October 2015. The postoperative course was uneventful. At six-months follow-up, the patient was able to assume a soft diet and reported a weight gain of 3 kg, with a significant improvement of the total symptom score and gastric emptying scintigraphy. Nevertheless, this encouraging clinical benefit gradually disappeared after the first year of follow-up. At the beginning of 2017, the patient experienced persistent episodes of vomiting and returned to jejunostomy feeding. The video shows the technique of laparoscopic Roux-en-Y gastrojejunostomy. After adhesiolysis and transhiatal mobilization of the distal gastric conduit, a 50 cm long Roux-en-Y alimentary limb was fashioned and anastomosed to the antrum. Post-operative course was uneventful and a gastrographin swallow study showed a satisfactory emptying of the conduit. At the 3-month follow-up the patient was able to resume a soft oral diet. Laparoscopic Roux-en-Y gastrojejunostomy appears to be safe and effective in treating refractory gastric outlet obstruction following Ivor-Lewis esophagectomy. Disclosure All authors have declared no conflicts of interest.

Repeated Gastric Pacemaker Lead Migration and Gastric Wall Perforation

Gastric Neurostimulators are increasingly used to treat gastroparesis, but can lead to complications including lead device or migration and perforation. To our knowledge, this is the first case report with repeated gastric wall perforation in the same patient. A 31 year old woman with idiopathic gastroparesis s/p gastric neurostimulator placement in 2007 presented for evaluation of a nonfunctioning device due to a low-charge battery, complicated shortly after by acute onset severe midepigastric abdominal pain for one day. Upon admission, a CT scan revealed that one of the device leads was protruding into the lumen of the stomach, penetrating the gastric wall. The patient underwent a diagnostic laparoscopy with removal of the displaced lead and installation of a new Enterra II gastric neurostimulator, with immediate resolution of her symptoms. However 8 months later the patient again experienced abdominal pain, and repeat abdominal CT scan showed recurrent lead penetration into the gastric lumen. She underwent repeat surgical intervention for permanent explant of the device given overall improvement of her symptoms. Patients with gastroparesis can have significant debilitation due to nausea, vomiting, dehydration and weight loss. Although the etiology is often unknown, it commonly affects diabetic or postsurgical patients and is thought to be due to impaired gastric nerve function failing to stimulate smooth muscle leading to decreased contractility1. When medical therapy with diet modification and pharmaceuticals fail, patients can undergo placement of a gastric neurostimulator, which is a small generator implanted underneath the abdominal skin with electrodes placed into the greater curvature of the stomach. Although many patients report improvement in gastric emptying and symptoms, complications including lead or device migration, implant pocket hematoma or infection can occur between 5-14% of cases.2 These often require surgery, and it is unclear how often these complications recur. It is important for clinicians to be aware of the potential long term risks of gastric neurostimulator placement as these devices come of age.

Effectiveness and feasibility of robotic gastric neurostimulator placement in patients with refractory gastroparesis.

Gastric neurostimulation (GNS) with Enterra® therapy device (Medtronic, Minneapolis, MN) appears as the last resort for patients with refractory gastroparesis. Currently, the device has Humanitarian Use status by Food and Drug Administration, thereby requiring further investigation. We aim to describe its feasibility and clinical outcomes using robotic technique. From June 2014 to September 2016, 15 consecutive patients underwent robotic insertion of Enterra® device. Patient demographics, comorbidities, and clinical outcomes including mortality, length of stay, readmission rates, reoperation and complications were retrospectively collected. Patients were also assessed based on a validated 14-point questionnaire regarding satisfaction with the operation, quality of life and symptomatic relief. Mean age was 41.6years±13.8 and there were 11 females (73.3%). No mortality was reported. The annual hospital admissions were reduced after GNS (2.5±4.1 vs. 3.6±4.4, p=0.004). The frequency of bloating (p=0.029) and severity of emesis (p=0.038), early satiety (p=0.042) and bloating (p=0.031) were reduced after GNS. The severity and frequency total scores were also improved after GNS (12.6±1.4 vs. 18.1±2.7, p=0.008 and 12.9±2.2 vs. 16.1±1.1, p=0.016, respectively). This is the first report describing the clinical experience with robotic insertion of GNS device. This approach is safe and feasible and seems to have similar long-term outcomes as laparoscopic technique. Potential advantages to robotic technique include enhanced dexterity and suturing of the device within gastric wall. Further experience with large prospective studies and randomized clinical trials may be warranted.

A5122 - Roux-en-Y Gastric Bypass for Refractory Gastroparesis – Effects on a Non-Obese Patient

Refractory gastroparesis is a debilitating disease process in which patients typically suffer from chronic abdominal pain, nausea, vomiting, malnutrition, and weight loss. If medical management is unsuccessful, surgical interventions include pyloromyotomy or pyloroplasty, gastric neurostimulator placement, feeding tube placement, and gastrectomy. Although roughly 30% of gastroparesis patients are diabetic, few are offered Roux-en-Y gastric bypass (RYGB) as a treatment option due to their low BMI stemming from their gastroparesis-inflicted weight loss. After thorough review of the literature, RYGB for refractory gastroparesis has only been previously described in the obese population. We further describe the novel utilization of RYGB for gastroparesis in a normal BMI, diabetic patient.

EUS-guided FNA biopsy of the muscularis propria of the antrum in patients with gastroparesis is feasible and safe

EUS-guided FNA biopsies of the muscularis propria of the gastric wall in patients with gastroparesis could replace the routine use of surgical full-thickness biopsies for assessing the loss of the interstitial cells of Cajal (ICCs) and cellular infiltrates in the myenteric plexus. We investigated the efficacy and safety of EUS-guided FNA biopsies of the muscularis propria of the gastric antrum in gastroparesis and compared the tissue with a surgically obtained full-thickness biopsy specimen in the same patient. This was a prospective, nonrandomized, feasibility trial. Patients with gastroparesis who were undergoing gastric neurostimulator placement were enrolled. Patients had a gastric wall measurement by radial EUS in the body and antrum of the stomach followed by linear EUS examination and FNA of the muscularis propria in the antrum by using a 19-gauge core needle. Within 24 hours, a full-thickness biopsy specimen of the antrum was obtained surgically during neurostimulator placement. Endoscopic and surgical specimens were compared for tissue morphology, number of ICCs (c-kit stain) and enteric neurons (S-100 stain), and fibrosis (trichome) for each patient. The correlation coefficient of the ICC count per high-power field was used to compare both specimens. Continuous data were compared by using a t test. Eleven patients (10 female, 1 male), with a mean age of 40.6 years, were enrolled in the trial. EUS-guided core biopsies were successful in obtaining sufficient tissue for the histologic assessment of ICCs in 9 patients (81%) and for the myenteric plexus in 6 patients (54%). There was a good correlation coefficient (0.65) when both surgical and endoscopic groups were compared for the loss of ICCs. Mild serosal bruising and/or localized hematoma formations were noted at the sites of EUS biopsies, but there were no serosal tears, perforations, or adverse effects on the hospitalization and outcomes. EUS-guided FNA of the gastric muscularis propria in patients with gastroparesis is safe and provides adequate tissue for full histologic assessment. (Clinical trial registration number: NCT01916460.).

OC-069 Non-invasive afferent vagus nerve stimulation (nvns) using gammacore (gc) in patients with treatment refractory gastroparesis awaiting enterra gastric neurostimulation

Introduction High frequency, low energy gastric neurostimulation (EnterraTM) is indicated for compassionate treatment of patients with refractory gastroparesis. Symptom improvement is reported in 50–60% of patients but not accompanied by improved gastric emptying. It is likely that gastric neurostimulation affects the gut-brain axis influencing autonomic afferents.1GammaCore (electroCore, LLC) is a non-invasive, afferent selective vagus nerve stimulator (nVNS) used for the treatment of migraine and cluster headache.2We report the first use of gammaCore (gC) in patients with refractory gastroparesis. Method 35 consecutive patients with intractable gastroparesis were invited to undergo a course of gC whilst awaiting funding for Enterra. The gC device delivers its stimulus to afferent vagus fibres as they cross the neck adjacent to the carotid arteries and it is programmed to deliver doses of 120 s. Patients were trained to deliver 2 doses (240 secs) to the left and right vagus nerve respectively. This dosing regimen was self-administered 8 hly (12 doses/day) for 2 weeks, increasing in week 3 to 3 doses 8 hly (18 doses/day). Patients were asked to grade their symptoms daily using the 9 item Gastroparesis Cardinal Symptom Index (GCSI) with a 5 point Likert scale. The GCSI was completed for 2 weeks prior and throughout the treatment period. At the end of the treatment period, the mean aggregated GSCI score at baseline was compared with the score of the final week of treatment. Clinically meaningful improvement was defined as a GCSI Likert scale reduction of ≥1. Results Twenty-three of the 35 patients (65.7%) used the gC as instructed and completed the diary. At 3 weeks, 8 patients (35%) had a ≥1 reduction in the aggregated GSCI score. Two patients who continued stimulation for more than three weeks had a delayed response, giving a total response rate of 43%. The response was evident within 1 week of commencing treatment in 8/10 responders (80%) and there was symptom recurrence within a week of stopping treatment in all the responders. There were no significant adverse events. Conclusion In this group of patients with treatment refractory gastroparesis, 1/3 failed to engage with short term nVNS. In compliant patients,43% recorded a fall of ≥1 in their aggregated GCSI score. As gC stimulates afferent vagus fibres, it is likely that the response is mediated at the level of the gut-brain axis. In refractory gastroparesis, gC might offer a new approach to symptom control. The dosing and duration of nVNS required to obtain an optimal response deserves further consideration. Disclosure of interest None Declared. References McCallum RW, et al. Neurogastroenterol Motil. 2010;22(2):161–7 Goadsby P, et al. Cephalgia 2014;34(12):986–93

Prospective Evaluation of Gastric Neurostimulation for Diabetic Gastroparesis in Canada

The efficacy of gastric neurostimulation therapy for diabetic gastroparesis (GP) in a 'real-life' Canadian setting has not been assessed. To assess changes in health-related quality of life (QoL), weekly vomiting frequency (WVF), total symptom score (TSS) and health care utilization 12 months before and after gastric neurostimulator implantation in a diabetic GP cohort. Medication-refractory diabetic GP patients (n=7, four female, mean age 42 years) were prospectively recruited from 2008 to 2012. QoL scores were self-administered and obtained at baseline, 24 and 48 weeks postimplantion. WVF and TSS were assessed similarly. Health care usage, measured as hospitalization frequency and medication cost, was obtained six and 12 months before and after implant. Changes from baseline to six and 12 months for all outcomes were compared. The mean ( ± SD) QoL according to EuroQol was significantly better at 24 weeks after the baseline measurement (baseline 29 ± 5, 24 weeks 52 ± 7; P = 0.03). The mean improvement in TSS was significantly better at one year postintervention (baseline score 35 ± 5 versus 12 months 27 ± 3; P = 0.03). Changes in Short-Form 36 Health Survey and WVF were not significant. Days of GP-related hospitalization were highly variable but decreased from a median of 71 days (range 0 to 227 days) to 29 days (range two to 334 days) one year before and after surgery, respectively (P = 0.735). Outpatient medication costs did not decrease to a significant extent. Gastric neurostimulation for diabetic GP appeared to show some beneficial palliative effects overall in the present small open-label series, but the effect is highly variable among patients, and placebo effect cannot be ruled out.

Mo1316 Two Hour Gastric Emptying Radionuclide Scintigraphy is Associated With False Diagnosis of Gastroparesis in Children

Introduction: Gastroparesis is a rare motor and sensory disorder of the stomach resulting in delayed gastric emptying in the absence of mechanical obstruction. Symptoms include nausea, vomiting, early satiety, bloating, abdominal pain, and weight loss. There is a paucity of data about the prevalence and etiology of gastroparesis in children, but the most common etiologies are post-viral, idiopathic and autonomic dysfunction disorders. Four hour radionuclide scintigraphic gastric emptying (GE) study is the recommended diagnostic study for gastroparesis. Many centers perform only a 2 hour GE study. There have been no comparison studies between these twomethods in pediatric patients. Methods:We conducted a retrospective review of the Mayo Clinic electronic data between April 2005 and June 2013. All children age (0-18) years diagnosed with gastroparesis, who underwent a 2 hour GE study, followed by 4 hour GE study were included. Children with history of gastric surgery (including gastric neurostimulator devices), diabetes, or on prokinetic medications were excluded. GE study was considered abnormal when GE was less than 7% at 1 hour, 31% at 2 hours and 81% at 4 hours. All demographic, symptoms and GE test results were recorded. This study was approved by the Mayo Clinic IRB. Results: A total 13 children (7 females, average age of 12 years) were identified. The most common reported symptoms at the time of both studies were abdominal pain (63%), nausea/ vomiting (38%), and bloating/ abdominal distention (16%). Many patients had multiple symptoms. Eighty five percent (n= 11) patients were diagnosed with gastroparesis using the 2 hour GE study. Out of 11 patients only 2 (18%) were confirmed with gastroparesis on the subsequent 4 hour GE study. Median time between the two studies was 6 months. None of the patients who had normal 2 hour study had an abnormal 4 hour study. Discussion: All patients who were diagnosed with gastroparesis by the 2 hours GE study continued to have symptoms despite trying different medications and diet modifications. Patients discontinued any prokinetic medications before repeating a 4 hour GE study. Most of the patients (85%) had a normal 4 hour GE study, despite persistence of their symptoms. These patients could have had GI symptoms due to a different etiology such as functional or other motility disorders (impaired accommodation). The improved GE results could be due to regression toward the mean, or true improvement in the gastric emptying function during the time elapsed between the two studies. Conclusion: The 2 hour radionuclide scintigraphic GE test is unreliable, and can result in false diagnosis of gastroparesis in children. Four hour GE radionuclide scintigraphy testing should be the standard practice.

Effectiveness of gastric neurostimulation in patients with gastroparesis.

Background:Patients with gastroparesis have significantly delayed gastric emptying because of impaired nerve function. Gastric neurostimulation from Enterra Therapy provides electrical pulses to the stomach tissue that promotes stimulation of stomach smooth muscle, thereby enhancing gastric emptying. This study evaluates the effectiveness of Enterra Therapy (Medtronic, Minneapolis, Minnesota) in reducing symptoms and improving the quality of life of patients with drug-refractory gastroparesis.Material and Methods:In this study 25 patients underwent minimally invasive, laparoscopic placement of the Enterra Therapy device. Patients were asked to rank their severity of symptoms and quality of life retrospectively by completing the Gastrointestinal Symptoms Rating Scale and Short Form 36 Health Survey with respect to their condition before and 6 months after initiation of Enterra Therapy.Results:Eighteen patients completed the surveys. Patients showed statistically significant improvement in their overall Gastrointestinal Symptoms Rating Scale scores and the mental health component of the Short Form 36 Health Survey.Discussion:Currently, Enterra Therapy has Humanitarian Use Device status, which means that more clinical evidence is needed to prove its effectiveness in gastroparesis. By showing that Enterra Therapy reduces symptoms of gastroparesis and improves patient quality of life, this study contributes to the increasing amount of data supporting its use and potential Food and Drug Administration approval.