Gastroparesis Patients Research Articles

Granisetron Transdermal System for Gastroparesis: A Prospective Study using the GCSI-Daily Diary

Granisetron transdermal system (GTS; Sancuso®), a patch delivering a 5-HT3 receptor antagonist, has been shown to improve nausea and vomiting in gastroparesis. Recent FDA guidance on gastroparesis suggests daily scoring of symptoms to show efficacy. Aim: Determine the efficacy and onset of therapeutic response of GTS in improving specific symptoms and overall symptoms of gastroparesis in patients with gastroparesis using a daily symptom diary for gastroparesis. Methods: Symptomatic patients with diabetic or idiopathic gastroparesis with nausea and/or vomiting were enrolled. Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) captured severity of symptoms at baseline for one week and during two weeks of treatment with GTS. Key Results: 14 patients (age 41.5±17 years; 13 females) with refractory gastroparesis (5 idiopathic, 9 diabetic) participated in this open label study. Nausea, early satiety, postprandial fullness, abdominal pain, GCSI-DD composite score, and overall symptom severity significantly improved (p<0.05) during treatment when compared to the baseline week. Nausea significantly decreased on day 5 (p<0.01) of treatment. Episodes of vomiting did not significantly change. Side effects included pruritus (2 patients) and redness (1) at the patch site, headache (1), constipation (1), and poor patch adherence (5). Conclusions & Inferences: GTS significantly reduced nausea severity in patients with gastroparesis. There were also significant improvements in early satiety, postprandial fullness, and abdominal pain. Nausea improvement occurred on the fifth day of treatment. Thus, GTS has therapeutic effect on nausea, as well as other gastroparesis symptoms, in patients with gastroparesis as captured using a daily diary for gastroparesis.

Exploring Symptom Severity, Illness Perceptions, Coping Styles, and Well-Being in Gastroparesis Patients Using the Common Sense Model.

This study aimed to examine the relationships between gastroparesis symptom severity, illness perceptions, coping styles, quality of life (QoL), and psychological distress in patients with gastroparesis, guided by the common sense model. One hundred and seventy-nine adults with gastroparesis (165 females, 14 males; mean age 41.82years) completed an online questionnaire. The Gastroparesis Cardinal Symptom Index was used to measure gastroparesis symptom severity, QoL was explored using the PAGI-QOL, illness perceptions were measured using the Brief Illness Perception Questionnaire, the Carver Brief COPE scale assessed coping styles, and psychological distress was investigated using the DASS21. Structural equation modeling resulted in a final model with excellent fit. Gastroparesis symptom severity directly influenced illness perceptions (β=.52, p<.001) and QoL (β=.30, p<.001). Illness perceptions directly influenced maladaptive coping (β=-.64, p<.001), psychological distress (β=-.32, p<.001), and QoL (β=.30, p=.01). Maladaptive coping directly influenced psychological distress (β=.62, p<.001), which in turn had a direct influence on QoL (β=-.38, p<.001). The final model showed that the influence of gastroparesis symptom severity on psychological distress was fully mediated by illness perceptions, while the influence on QoL was partially mediated by illness perceptions. The study provides guidance for the development of psychological interventions targeted toward improving mediating psychological factors.

Gastric Per Oral Endoscopic Myotomy (G-POEM) for the Treatment of Refractory Gastroparesis: Early Experience.

Gastric per oral endoscopic myotomy (G-POEM) of the pylorus is a technique that is recently being used to treat gastroparesis. Our aim was to report our experience in performing G-POEM for refractory gastroparesis of different etiologies and determine symptom improvement. Thirteen patients undergoing G-POEM are reported. Pre- and post-procedure gastric emptying study (GES) and PAGI-SYM for symptom severity were obtained. Patients underwent G-POEM by creating a submucosal tunnel starting in the greater curvature of the distal antrum and extending it to the beginning of the duodenal bulb, followed by a full thickness pyloromyotomy. All 13 gastroparesis patients successfully underwent G-POEM (one diabetic [DGp], four idiopathic [IGp], eight postsurgical [PSGp]). Postsurgical patients included 4s/p esophagectomy for esophageal cancer, 3s/p Nissen fundoplication, and 1s/p esophagectomy for achalasia. There were no procedure-related side effects. Of 11 patients completing follow-up questionnaires, eight were improved subjectively (four patients reported considerably better, four patients somewhat better, one unchanged, and two worse). Individual symptom severity scores tended to improve, particularly vomiting, retching, and loss of appetite. Of six patients that had post-G-POEM GES; GES improved in four, unchanged in one, and worsened in one). G-POEM for treatment of refractory gastroparesis appears to be a feasible and safe technique that can be successfully performed in patients with a variety of etiologies including different types of postsurgical gastroparesis. Our initial experience suggests that the majority of patients report some improvement in symptoms, particularly symptoms of vomiting, retching, and loss of appetite. Further experience is needed to determine the efficacy and safety of G-POEM and predict those who best respond to this treatment.

Formulation development and evaluation of nifedipine as pylorospasm inhibitor

Introduction: In this study, different nifedipine-loaded formulations were prepared to treat pylorospasm, a sphincter muscle disorder characterized by delayed gastric emptying process. The efficacy of formulation was evaluated in patients by subjective assessment, gamma scintigraphic approaches, and confocal microscopy.Methods: Nifedipine-loaded different formulations such as sucrose bead, pellets, and microparticles (slugging method, ionotropic gelation, and chemical denaturation) were designed. The studies were performed on 50 subjects, of which 30 subjects were treated with optimized nifedipine loaded microcapsules while 20 subjects were given capsule becosule-Z as a control. The efficacy of formulation was assessed by comparing symptoms like dyspepsia, abdominal pain, abdominal fullness, poor appetite, nausea, vomiting, and irregular motion. The effectiveness of formulation was also assessed by gamma scintigraphic studies by determining the rate of emptying of a radioactivity labeled standard meal from patients’ stomach into the duodenum. Confocal microscopy was used to assess targeting potential of developed formulation.Results: Drug-loaded alginate-chitosan microcapsules were found to be satisfactory, in terms of controlled drug release, surface morphology, and bioadhesive properties and thus selected for in vivo studies. Clinical studies revealed the efficacy of formulation in abolishing various GI symptoms at high altitude. Associated symptoms such as dyspepsia, abdominal pain, poor appetite, nausea, vomiting, and irregular motion were recovered by 75, 62, 76.5, 86.7, 85.7, and 37.5%, respectively in nifedipine-treated patients. In comparison, 73.7, 40, 33.3, 40, 20, and 0% recoveries were observed in patients given control treatment only. Gamma Scintigraphic studies in lab also revealed 2.425 ± 0.245 (p < .05) times improvement in gastric emptying rate in patients with diabetic gastroparesis. Confocal analysis showed better targeting and penetration in pyloric region when formulation was administered in form of high-density microcapsules.Conclusions: Results strongly suggest that nifedipine loaded mucoadhesive formulation has a targeting potential which accelerates gastric emptying process in gastroparesis patients, and thus the formulation might prove useful as a potent prokinetic agent.

Analysis of gastric myoelectrical activity from the electrogastrogram signals based on wavelet transform and line length feature.

Electrogastrogram is used for the abdominal surface measurement of the gastric electrical activity of the human stomach. The electrogastrogram technique has significant value as a clinical tool because careful electrogastrogram signal recordings and analyses play a major role in determining the propagation and coordination of gastric myoelectric abnormalities. The aim of this article is to evaluate electrogastrogram features calculated by line length features based on the discrete wavelet transform method to differentiate healthy control subjects from patients with functional dyspepsia and diabetic gastroparesis. For this analysis, the discrete wavelet transform method was used to extract electrogastrogram signal characteristics. Next, line length features were calculated for each sub-signal, which reflect the waveform dimensionality variations and represent a measure of sensitivity to differences in signal amplitude and frequency. The analysis was carried out using a statistical analysis of variance test. The results obtained from the line length analysis of the electrogastrogram signal prove that there are significant differences among the functional dyspepsia, diabetic gastroparesis, and control groups. The electrogastrogram signals of the control subjects had a significantly higher line length than those of the functional dyspepsia and diabetic gastroparesis patients. In conclusion, this article provides new methods with increased accuracy obtained from electrogastrogram signal analysis. The electrogastrography is an effective and non-stationary method to differentiate diabetic gastroparesis and functional dyspepsia patients from the control group. The proposed method can be considered a key test and an essential computer-aided diagnostic tool for detecting gastric myoelectric abnormalities in diabetic gastroparesis and functional dyspepsia patients.

Efficacy of Gastric Electrical Stimulation for Gastroparesis: US/European Comparison.

BackgroundGastric electrical stimulation (GES) is used in both the US and Europe, but little research has investigated the demographics of gastroparesis patients receiving GES by geographic location.MethodsWe compared data from 380 patients, 296 female and 84 males, mean age 42 years, 246 idiopathic (ID), 107 diabetic (DM), and 27 post-surgical (PS). The statistical significance was calculated by Chi-square test and a P-value obtained for ID, DM, and PS. The statistical significance was calculated by Fischer exact test and a P-value obtained comparing male vs. female.ResultsEuropean centers had 61 GES patients compared to 319 from the US. In Europe, 100% of patients had gastric emptying test (GET) values available; in the US, it was 75% of patients. European centers had more DM patients (59%) than the US (22%), and a smaller proportion of ID patients (25%) than the US (72%). There was a statistical difference between the causes of gastroparesis in the patients receiving GES (P-value < 0.00001). There was also significant difference in the gender of the patients receiving GES, with a greater proportion of women in the US (P value = 0.0023).ConclusionsComparing GES in US vs. Europe demonstrated significant differences in gastroparesis demographics and percentage of patients with GET data. After analyzing the previously discussed results and reviewing recent updates in evidence-based medicine guidelines, the discrepancy and variance in patient populations in the US and Europe emphasizes the need for a database that allows better analysis and treatment of gastroparesis patients worldwide including stimulation therapies.

Fluoroscopic gastric peroral endoscopic pyloromyotomy (G-POEM) in patients with a failed gastric electrical stimulator

BackgroundGastric electrical stimulators (GESs) have been used to treat refractory gastroparesis in patients who fail initial therapies such as dietary modifications, control of psychological stressors and pharmacologic treatment. More recently, gastric peroral endoscopic pyloromyotomy (G-POEM) has emerged as a novel endoscopic technique to treat refractory gastroparesis. We present a case series of patients with refractory gastroparesis who failed treatment with an implanted GES that were safely treated with G-POEM performed under fluoroscopy as a salvage therapy.MethodsCases of G-POEM performed on patients with refractory gastroparesis who failed treatment with a GES were retrospectively reviewed. All G-POEM procedures were performed under fluoroscopic guidance with the GES still in place. Gastroparesis Cardinal Symptoms Index (GCSI) and gastric emptying scintigraphy were assessed before and after the procedure. Patients were followed up for up to 18 months post procedure.ResultsFive patients underwent G-POEM after failing treatment with a GES. Under fluoroscopy, the GES and their leads were visualized in different parts of the stomach. One GES lead was observed at the antrum near the myotomy site. All procedures were successfully completed without complications. Patients’ GCSI decreased by an average of 62% 1 month post procedure. Patients also had notable improvements in gastric emptying 2 months post procedure.ConclusionIn patients with refractory gastroparesis who have failed treatment with a GES, G-POEM can be safe and effective without removing the GES. To visualize the GES and avoid cutting GES leads during myotomy, the procedure should be performed under fluoroscopy.

Idiopathic gastroparesis is associated with specific transcriptional changes in the gastric muscularis externa.

The molecular changes that occur in the stomach that are associated with idiopathic gastroparesis are poorly described. The aim of this study was to use quantitative analysis of mRNA expression to identify changes in mRNAs encoding proteins required for the normal motility functions of the stomach. Full-thickness stomach biopsy samples were collected from non-diabetic control subjects who exhibited no symptoms of gastroparesis and from patients with idiopathic gastroparesis. mRNA was isolated from the muscularis externa and mRNA expression levels were determined by quantitative reverse transcriptase (RT)-PCR. Smooth muscle tissue from idiopathic gastroparesis patients had decreased expression of mRNAs encoding several contractile proteins, such as MYH11 and MYLK1. Conversely, there was no significant change in mRNAs characteristic of interstitial cells of Cajal (ICCs) such as KIT or ANO1. There was also a significant decrease in mRNA-encoding platelet-derived growth factor receptor α (PDGFRα) and its ligand PDGFB and in Heme oxygenase 1 in idiopathic gastroparesis subjects. In contrast, there was a small increase in mRNA characteristic of neurons. Although there was not an overall change in KIT expression in gastroparesis patients, KIT expression showed a significant correlation with gastric emptying whereas changes in MYLK1, ANO1 and PDGFRα showed weak correlations to the fullness/satiety subscore of patient assessment of upper gastrointestinal disorder-symptom severity index scores. Our findings suggest that idiopathic gastroparesis is associated with altered smooth muscle cell contractile protein expression and loss of PDGFRα+ cells without a significant change in ICCs.

Botox Injection: A Salvage Therapy for Diabetic Gastroparesis in a Patient With Prior Gastrojejunal Anastomosis

Gastroparesis (GP) is a disorder of gastric motility resulting in delayed gastric emptying. Diabetes mellitus is the most commonly recognized systemic disease associated with gastroparesis. With limited medical options, use of pre-pyloric botulinum toxin A(BT-A) has shown to be effective and is offered as a salvage therapy in cases of refractory GP. A 42 year old woman with past medical history of type I diabetes mellitus (DM), diabetic neuropathy, severe DGP presented with abdominal pain, nausea and vomiting for five days associated with early satiety and postprandial fullness. The physical exam was remarkable for epigastric tenderness. Labs showed blood sugar of 388 mg/dL, hemoglobin A1C of 9.4 and metabolic alkalosis. She has a long standing history of severe DGP refractory to previous medical therapy. She has failed a trial of gastric pacemaker and feeding jejunostomy tube multiple times. She had transient response to gastrojejunostomy. Gastric emptying study revealed severe GP (greater than 35% activity in stomach at 4 hours). A decision to inject botulism toxin endoscopically was made considering non response to medical and surgical therapy. An upper endoscopy was performed which demonstrated a normal looking gastrojejunal anastomosis and no endoscopic evidence of stenosis, stricture or mass in the pylorus. 200 units botulinum toxin was diluted in 10 ml of saline. The area around the pylorus was successfully injected circumferentially with 8 ml of diluted botox solution and area around gastro-jejunal anastomosis was successfully injected with 2 ml of diluted botox solution with no immediate complications. Patient was subsequently started on PO diet which she tolerated well with clinical improvement in her symptoms. Antroduodenal dyscoordination is found in DGP, where the actions of the pylorus are not coordinated with that of the antrum. Thus, the antrum contracts against a closed pylorus, preventing emptying of gastric contents. The use of BT-A injection to relieve symptoms and improve quality of life in patients with severe gastroparesis refractory to standard therapy is a safe and inexpensive treatment before considering surgery. Use of botox was particularly challenging in this case as patient had prior gastrojejunal anastomosis. This case highlights the success of botox injection in treatment of diabetic gastroparesis in a challenging patient with prior gastrojejunal anastomosis.Figure: Prepyloric channel circumferential botox injection.

Gastroparesis Patientsʼ Willingness to Take Risks With Medications

Introduction: Treating gastroparesis (GP) can be difficult as there is only one FDA approved medication for the treatment of GP and it is associated with side effects in a substantial portion of patients. The willingness of patients to take risks associated with medications to treat GP is unknown. Aims: To evaluate patients with documented GP and assess their willingness to take risks associated with medications used to treat GP. Methods: A questionnaire was developed, revised after a focus group with GP patients, and mailed to patients previously identified as having documented gastroparesis (those with symptoms consistent with GP, a normal EGD, and a delayed 4 hour gastric emptying scan). The survey included questions on demographics, symptoms, and medication use, in addition to validated questionnaires assessing anxiety and depression (HAD) and impulsivity. It contained a standard gamble to evaluate respondents' willingness to take medication risks. Results: Questionnaires were sent to 207 GP patients, 91 were returned (44%) and evaluated. 76% were female; the mean age was 49 years. 40% were diabetic. Patients reported an average of 10.5 years of GP symptoms. 51% of patients self-reported their GP symptoms as severe while 33% described symptoms as moderate. GP patients reported that they would accept a median 10% risk of sudden death for a 90% chance to cure their symptoms using a hypothetical medication. Patients with self-reported severe GP symptoms were found to have a significantly increased willingness to take risks associated with medications used to treat GP. Of note, only 2% of patients reported that they routinely take risks in daily life. Patient anxiety as assessed by HADS was found to have a significant negative correlation with willingness to take GP medication associated risks. Conclusion: GP patients are willing to tolerate relatively high risks associated with a hypothetical medication to cure their symptoms. Patients with severe GP symptoms were more willing to take these medication risks. Patient anxiety was associated with a decreased willingness to accept medication risks. To our knowledge, this is the first study quantifying GP patients' willingness to accept medication associated risk. These results provide information that may help clinicians guide their patients through the complex maze of gastroparesis therapies, and their associated risks.

Randomized Controlled Double-blind Trial Comparing Haloperidol Combined With Conventional Therapy to Conventional Therapy Alone in Patients With Symptomatic Gastroparesis.

Gastroparesis is a debilitating condition that causes nausea, vomiting, and abdominal pain. Management includes analgesics and antiemetics, but symptoms are often refractory. Haloperidol has been utilized in the palliative care setting for similar symptoms. The study objective was to determine whether haloperidol as an adjunct to conventional therapy would improve symptoms in gastroparesis patients presenting to the emergency department (ED). This was a randomized, double-blind, placebo-controlled trial of adult ED patients with acute exacerbation of previously diagnosed gastroparesis. The treatment group received 5 mg of haloperidol plus conventional therapy (determined by the treating physician). The control group received a placebo plus conventional therapy. The severity of each subject's abdominal pain and nausea were assessed before intervention and every 15 minutes thereafter for 1 hour using a 10-point scale for pain and a 5-point scale for nausea. Primary outcomes were decreased pain and nausea 1 hour after treatment. Of the 33 study patients, 15 were randomized to receive haloperidol. Before treatment, the mean intensity of pain was 8.5 in the haloperidol group and 8.28 in the placebo group; mean pretreatment nausea scores were 4.53 and 4.11, respectively. One hour after therapy, the mean pain and nausea scores in the haloperidol group were 3.13 and 1.83 compared to 7.17 and 3.39 in the placebo group. The reduction in mean pain intensity therapy was 5.37 in the haloperidol group (p ≤ 0.001) compared to 1.11 in the placebo group (p = 0.11). The reduction in mean nausea score was 2.70 in the haloperidol group (p ≤ 0.001) and 0.72 in the placebo group (p = 0.05). Therefore, the reductions in symptom scores were statistically significant in the haloperidol group but not in the placebo group. No adverse events were reported. Haloperidol as an adjunctive therapy is superior to placebo for acute gastroparesis symptoms.

Gastroparesis: Medical and Therapeutic Advances.

Gastroparesis is a chronic, bothersome, and often disabling neuromuscular disorder of the upper gastrointestinal tract. The most frequently reported symptoms of gastroparesis include nausea, vomiting, epigastric pain, early satiety, and unintentional weight loss. Etiologies of gastroparesis include diabetes, connective tissue disorders, prior infection, mesenteric ischemia, and post-surgical complications. The largest category of gastroparesis patients is comprised of those in whom no definitive cause can be identified (idiopathic gastroparesis). The individual and societal burden of gastroparesis is substantial. It considerably reduces patients' quality of life accompanied by a significant negative impact to the healthcare system. The current treatments of gastroparesis are less than ideal. Dietary modification may improve symptoms in patients with mild disease. Metoclopramide is the only medication currently approved for the treatment of gastroparesis; however, it is associated with adverse effects in a sizable proportion of patients. Other medications are frequently employed to treat symptoms of nausea and vomiting, although technically all are used off-label since they are not FDA approved for the treatment of gastroparesis. These data highlight the need to identify novel, more effective treatment options for this disabling disease. This review will provide a brief synopsis on the epidemiology, etiology, and impact of gastroparesis, discussing new therapeutic advances.

Taste and Smell Disturbances in Patients with Gastroparesis and Gastroesophageal Reflux Disease.

Background/AimsPatients with gastroparesis and gastroesophageal reflux disease (GERD) often report decreased enjoyment when eating. Some patients remark that food does not smell or taste the same. To determine if taste and/or smell disturbances are present in patients with gastroparesis and/or GERD and relate these to gastrointestinal symptom severity.MethodsPatients with gastroparesis and/or GERD completed questionnaires evaluating taste and smell (Taste and Smell Survey [TSS]), Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM), and Demographics. TSS questioned the nature of taste/smell changes and the impact on quality of life. PAGI-SYM was used to calculate Gastroparesis Cardinal Symptom Index (GCSI) and Heartburn and Regurgitation Score (HB/RG).ResultsSeventy-six subjects were enrolled: healthy controls (n = 13), gastroparesis alone (n = 30), GERD alone (n = 10), and both gastroparesis and GERD (n = 23). Taste and smell disturbances were higher in patients with gastroparesis, GERD, and both gastroparesis and GERD compared to healthy controls. Taste and smell abnormalities were significantly correlated (r = 0.530, P < 0.001). Taste score was strongly correlated with HB/RG (r = 0.637, P < 0.001) and with GCSI (r = 0.536, P < 0.001). Smell score was also strongly correlated to HB/RG (r = 0.513, P < 0.001) and GCSI (r = 0.495, P < 0.001).ConclusionsTaste and smell abnormalities are prominent in gastroparesis and GERD patients. Abnormalities in taste and smell are significantly correlated with both gastroparesis and GERD symptom severity. Awareness of this high prevalence of taste and smell dysfunction among patients with gastroparesis and GERD may help to better understand the food intolerances these patients often have.

740 Quality of Life and Clinical Outcomes of Refractory Gastroparesis Patients After Gastric Per Oral Endoscopic Pyloromyotomy (Gpoem): A Single Center Experience

740 Quality of Life and Clinical Outcomes of Refractory Gastroparesis Patients After Gastric Per Oral Endoscopic Pyloromyotomy (Gpoem): A Single Center Experience

Gastric neuromuscular histology in patients with refractory gastroparesis: Relationships to etiology, gastric emptying, and response to gastric electric stimulation

The aims of this study were to describe the histology in gastroparesis, specifically to relate histopathology to etiology of gastroparesis (idiopathic and diabetic gastroparesis), gastric emptying, and clinical response to gastric electric stimulation. Full thickness gastric body sections obtained during insertion of gastric stimulator in gastroparetics were stained with Hematoxylin & Eosin, Masson Trichrome and immunohistochemical stains for Neuron-Specific Enolase and c-Kit. In all, 145 gastroparetics (71 diabetics, 71 idiopathic, 2 post-surgical, and 1 chronic intestinal pseudo-obstruction) had full thickness gastric body biopsies. A lymphocytic infiltrate was seen in the intermyenteric plexus in 22 diabetic and 23 idiopathic gastroparesis patients. Fibrosis was present in the inner circular layer in 13 diabetic and 15 idiopathics and in the outer longitudinal layer in 46 diabetic and 51 idiopathics. Diabetic gastroparesis had less ganglion cells (3.27±1.82 vs 4.81±2.81/hpf; P<.01) and less ganglia (0.90±0.44 vs 1.10±0.50/hpf; P=.01) than idiopathic gastroparesis. Interstitial cells of Cajal (ICC) count was slightly lower in the inner circular layer in diabetic than idiopathics (2.77±1.47 vs 3.18±1.34/hpf; P=.08). Delayed gastric emptying was associated with reduced ICCs in the myenteric plexus. Global therapeutic response to gastric electric stimulation was inversely related to ganglia/hpf (R=-.22; P=.008). In diabetics, improvements in nausea, vomiting, and abdominal pain were inversely related to fibrosis. Histologic assessment of full thickness gastric biopsy specimens allows correlation of histopathology to the gastroparesis disease process, its etiology, gastric emptying, and response to gastric electric stimulation treatment.

527 - Gastric Per Oral Endoscopic Myotomy (G-POEM) for the Treatment of Refractory Gastroparesis: Early Experience

Gastric per oral endoscopic myotomy (G-POEM) of the pylorus is a technique that is recently being used to treat gastroparesis. Our aim was to report our experience in performing G-POEM for refractory gastroparesis of different etiologies and determine symptom improvement. Thirteen patients undergoing G-POEM are reported. Pre- and post-procedure gastric emptying study (GES) and PAGI-SYM for symptom severity were obtained. Patients underwent G-POEM by creating a submucosal tunnel starting in the greater curvature of the distal antrum and extending it to the beginning of the duodenal bulb, followed by a full thickness pyloromyotomy. All 13 gastroparesis patients successfully underwent G-POEM (one diabetic [DGp], four idiopathic [IGp], eight postsurgical [PSGp]). Postsurgical patients included 4 s/p esophagectomy for esophageal cancer, 3 s/p Nissen fundoplication, and 1 s/p esophagectomy for achalasia. There were no procedure-related side effects. Of 11 patients completing follow-up questionnaires, eight were improved subjectively (four patients reported considerably better, four patients somewhat better, one unchanged, and two worse). Individual symptom severity scores tended to improve, particularly vomiting, retching, and loss of appetite. Of six patients that had post-G-POEM GES; GES improved in four, unchanged in one, and worsened in one). G-POEM for treatment of refractory gastroparesis appears to be a feasible and safe technique that can be successfully performed in patients with a variety of etiologies including different types of postsurgical gastroparesis. Our initial experience suggests that the majority of patients report some improvement in symptoms, particularly symptoms of vomiting, retching, and loss of appetite. Further experience is needed to determine the efficacy and safety of G-POEM and predict those who best respond to this treatment.

Central Nervous System (CNS) Mechanisms of Nausea in Gastroparesis: An fMRI Based Case–Control Study

Background/Aims Nausea is a major complaint of gastroparesis (GP), and the pathophysiology of this condition is poorly understood. Therefore, this study utilized fMRI to investigate the possible central nervous system (CNS) mechanisms of nausea in 10 GP patients versus 8 healthy controls (HCs).

Exploration of the psychosocial issues associated with gastroparesis: a qualitative investigation.

To build on the understanding of how individuals experience gastroparesis, how gastroparesis impacts on their lives and how they adapt to living with gastroparesis. Gastroparesis is a neurogastroenterological disorder associated with increased psychological distress and reduced quality of life. Research shows that gastroparesis poses a significant burden across many facets of life; however, less is known about how individuals cope and adapt to living with the condition. The study employed an interpretive phenomenological approach with semistructured interviews and thematic analysis. Ten gastroparesis patients were interviewed over the telephone (n=8), Skype (n=1) or face-to-face (n=1). All interviews were audio-recorded and transcribed. Key themes identified: (1) frustration, (2) identity and (3) coping and adaptation. Gastroparesis patients experience significant frustration around their diagnostic journey, being misunderstood and the burden of living with the illness. Patients differed in how they identified with the illness, and this appeared to be associated with adaptation and whether they remained socially engaged. Gastroparesis is associated with significant frustration and burden; however, some patients adapt to living with the condition more effectively than others. Identity appears to play an important role in this relationship. Support aimed at fostering a health-focused and resilient identity may assist gastroparesis patients in adaptation. The findings of this study can help nurses and other healthcare professionals better understand the experience of living with gastroparesis and the factors that help patients best adapt to living with the condition. Nurses can help promote resilience in patients by discussing the importance of being health-focused rather than illness-focused. Nurses can also support patients by helping them problem-solve issues that may arise around social eating and remaining socially engaged.

Gastroparesis: Quality of Life and Health Care Utilization.

Gastroparesis (GP) patients suffer from recurrent symptoms of nausea, vomiting, early satiety, and abdominal pain. The impact of GP on quality of life (QoL), health care utilization and daily activities is not well understood. Part 1: 398 adult patients (≥18 y) with documented GP (symptoms >6 mo) were surveyed to assess QoL and pain using the Short Form 36 and McGill pain questionnaires. Part 2: 491 adult GP patients were surveyed to evaluate employment status, work and daily activities, medication use, physician visits, diagnostic testing, emergency room visits, and hospitalizations related to their GP symptoms. Both protocols received Institutional Review Board approval. Part 1: 250 fully evaluable surveys were returned (63%). The mean age was 46.8 years (range, 18 to 84 y); 78% were women. Mean Short Form 36 scores for mental health (56.9) and social functioning (68.1) were analogous to scores for patients with serious chronic medical disorders and depression. Pain scores were lower in patients with idiopathic GP compared with diabetic GP. Part 2: 228 evaluable surveys were analyzed (58.3% response rate). The mean age was 49.6 (19 to 86 y); 77.2% were women. GP symptoms reduced daily activities in 67.5% and lowered annual income in 28.5%. In total, 11% were disabled due to GP symptoms. GP reduces patients' QoL and places a significant financial burden on the health care system. Treatment strategies for GP patients should be broad based and incorporate pain management, psychological evaluation and management, and strategies to improve overall well-being with a return to work and daily activities.

Diabetic and idiopathic gastroparesis is associated with loss of CD206-positive macrophages in the gastric antrum.

Animal studies have increasingly highlighted the role of macrophages in the development of delayed gastric emptying. However, their role in the pathophysiology of human gastroparesis is unclear. Our aim was to determine changes in macrophages and other cell types in the gastric antrum muscularis propria of patients with diabetic and idiopathic gastroparesis. Full thickness gastric antrum biopsies were obtained from patients enrolled in the Gastroparesis Clinical Research Consortium (11 diabetic, 6 idiopathic) and 5 controls. Immunolabeling and quantitative assessment was done for interstitial cells of Cajal (ICC) (Kit), enteric nerves protein gene product 9.5, neuronal nitric oxide synthase, vasoactive intestinal peptide, substance P, tyrosine hydroxylase), overall immune cells (CD45) and anti-inflammatory macrophages (CD206). Gastric emptying was assessed using nuclear medicine scintigraphy and symptom severity using the Gastroparesis Cardinal Symptom Index. Both diabetic and idiopathic gastroparesis patients showed loss of ICC as compared to controls (Mean [standard error of mean]/hpf: diabetic, 2.28 [0.16]; idiopathic, 2.53 [0.47]; controls, 6.05 [0.62]; P=.004). Overall immune cell population (CD45) was unchanged but there was a loss of anti-inflammatory macrophages (CD206) in circular muscle (diabetic, 3.87 [0.32]; idiopathic, 4.16 [0.52]; controls, 6.59 [1.09]; P=.04) and myenteric plexus (diabetic, 3.83 [0.27]; idiopathic, 3.59 [0.68]; controls, 7.46 [0.51]; P=.004). There was correlation between the number of ICC and CD206-positive cells (r=.55, P=.008). Enteric nerves (PGP9.5) were unchanged: diabetic, 33.64 (3.45); idiopathic, 41.26 (6.40); controls, 46.80 (6.04). Loss of antral CD206-positive anti-inflammatory macrophages is a key feature in human gastroparesis and it is associates with ICC loss.