Gastroparesis Cardinal Symptom Index Total Score Research Articles

Clinical Outcomes of a Large, Prospective Series of Gastric Electrical Stimulation Patients Using a Multidisciplinary Protocol.

Gastric electrical stimulation (GES) is an intervention used in the treatment of medically refractory gastroparesis. There are few large series demonstrating efficacy over a long-term follow-up period. This study reports clinical outcomes for patients from a single institution up to 5 years. A prospective database of patients undergoing GES implantation for gastroparesis was collected and reviewed. Patients were selected according to a multi-disciplinary institutional protocol. Baseline characteristics, including age, sex, smoking history, etiology of gastroparesis, and duration of gastroparesis symptoms, were collected. Symptomatic response was evaluated utilizing Gastroparesis Cardinal Symptom Index (GCSI) surveys pre-operatively and at subsequent follow-up visits. Other clinical outcome variables include medication use, hospitalizations due to gastroparesis, and overall satisfaction with symptom relief. Patient outcomes regarding reoperation and explantation were also recorded. 157 patients underwent GES at our institution since 2012. GCSI scores were collected in all patients at baseline, in 141 patients at 1 year follow-up, and in 110 patients at 5 years follow-up. Symptom severity in all 9 gastroparesis symptoms evaluated by the GCSI, as well as the total GCSI score, was reduced significantly at 1 year post-operatively, and these results were sustained at 5-year follow-up. Use of prokinetic and antiemetic medications was reduced during the follow-up period. Hospitalizations due to gastroparesis symptoms were also reduced. GES devices were explanted in 5 patients, 12 patients required generator exchanges, and 7 patients required reoperation due to displaced/eroded device leads during the study period. Gastric electrical stimulation is associated with sustained symptomatic relief, reduced reliance on medications, and reduced hospitalizations in gastroparesis patients selected utilizing our institutional protocol.

902-P: Screening for Gastric Motor Abnormalities in Pediatric Patients with Type 1 Diabetes: A Cross-Sectional Study

Diabetes is the 2nd most common cause of delayed gastric emptying in adults. As a result, patients with type 1 diabetes are at increased risk of gastric motor abnormalities that can include delayed gastric emptying (gastroparesis) and the related symptoms. Limited information exists regarding presence of gastric motility disorders in youth with type 1 diabetes. An improved understanding of whether these gastric motility symptoms are present may influence screening, diagnosis, treatment, and quality of life. A cross sectional study was conducted to assess symptoms suggestive of gastroparesis in pediatric patients with type 1 diabetes using the standardized Gastroparesis Cardinal Symptom Index (GCSI) questionnaire. The GCSI consists of 9 questions to assess the presence and severity of gastric motility symptoms. Severity is rated from none (0) to very severe (5) using a likert scale and three symptom subscale (presence of nausea/vomiting, fullness/early satiety, and bloating). The total GCSI score is calculated as the mean of the three subscales. A GCSI score ≥ 1.9 has been associated with delayed gastric emptying. Initial data from 247 patients with type 1 diabetes; mean±SD age 18.1±3.4 years (range 15-20 years old), 61% female, 90% Caucasian, duration of the disease 8.4 ±5.3 years, A1c 8.1±1.8% who answered the GCSI questionnaire found 190 (77%) had at least one symptom associated with gastric motility disorder. Nausea was the most common symptom (75%) followed by stomach fullness (63%). Of those with at least one positive symptom, 37 (20%) had a score ≥ 1.9. Those with a GCSI score ≥ 1.9 were older (19.5 vs. 17.8, p=0.008), but there was no association with race, sex, body mass index, duration of the disease, or glycemic control, as measured by HbA1c. Gastrointestinal symptoms suggestive of gastric motor abnormalities, as measured by the GCSI questionnaire are present in youth with type 1 diabetes. Older patients may be at higher risk. Disclosure G. Mashali: None. A. A. Kaul: None. L. M. Dolan: None. J. C. Khoury: None. A. S. Shah: None.

Gastroparesis Symptoms Associated with Intestinal Hypomotility: An Explorative Study Using Wireless Motility Capsule.

ObjectiveGastric emptying measurements are mandatory in gastroparesis diagnostics, but the association between delayed emptying and symptoms is questionable. It is imperative to find biomarkers better correlated to symptom generation. Hence, we examined the association between symptom severity and gastrointestinal motility measured by wireless motility capsule.Patients and MethodsIn this prospective single-centre study, patients with gastroparesis symptoms were simultaneously investigated with gastric emptying scintigraphy and wireless motility capsule, measuring regional transit times and contractility parameters. Symptom severity was assessed with the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM), including the Gastroparesis Cardinal Symptom Index (GCSI).ResultsWe included 107 patients (70% women). In the whole patient group, nausea correlated with the gastric (rs = −0.31, p = 0.007), small bowel (rs = −0.41, p < 0.001) and colonic (rs = −0.33, p = 0.012) motility indices. In patients with idiopathic etiology, nausea correlated with small bowel motility index (rs = −0.81, p < 0.001) and mean stomach pressure (rs = −0.64, p = 0.013). We also found negative correlations between total GCSI score and maximum pressure of the small bowel (rs = −0.77, p < 0.001) and colon (rs = −0.74, p = 0.002). In diabetes patients, total PAGI-SYM score correlated with colonic motility index (rs = −0.34, p = 0.012), and mean pressure of the colon correlated with upper abdominal pain (rs = −0.37, p = 0.007). We found no association between symptoms, gastric emptying nor any other transit times.ConclusionIn patients with gastroparesis symptoms, we found that symptom severity was associated with intestinal hypomotility. Based on these results, gastroparesis diagnostics should also include an evaluation of the small bowel and colon.

S1343 EndoFLIP and Pyloric Dilation for Gastroparesis Symptoms Refractory to Pyloromyotomy/Pyloroplasty

INTRODUCTION: Gastroparesis (Gp) patients may undergo pyloromyotomy/pyloroplasty for chronic refractory symptoms. However, some patients have persistent symptoms. It is unknown if balloon dilation is an effective treatment strategy in these patients. We aimed to: 1) Assess if pyloric Through the Scope (TTS) balloon dilation results in symptom improvement in Gp patients with suboptimal response to pyloromyotomy/pyloroplasty; 2) Determine Endoscopic Functional Luminal Imaging Probe (EndoFLIP) characteristics of these patients before dilation. METHODS: Patients with severe Gp refractory to pyloromyotomy/pyloroplasty seen from 2/2019 to 3/2020 underwent pyloric TTS dilation to 18, 19 and 20 mm after assessing the pyloric characteristics at 30-, 40-, and 50-ml EndoFLIP distension volumes. Patients completed Gastroparesis Cardinal Symptom Index (GCSI) pre-procedurally, and GCSI and Clinical Patient Grading Assessment Scale (CPGAS) on follow-ups. RESULTS: Thirteen (10 females) patients (mean age 45.2 ± 5.1 years) with Gp and prior pyloric surgeries (laparoscopic pyloroplasty = 6, endoscopic pyloromyotomy = 5, laparoscopic pyloromyotomy = 1) presented with severe Gp symptoms (mean GCSI total score 3.4 ± 0.3, Table 1). TTS dilation was performed after assessing pyloric characteristics on EndoFLIP. Overall, there was improvement of symptoms at 1-month follow-up (mean GCSI total score 3.0 ± 0.4, P = 0.04, Table 2; mean CPGAS score 1.6 ± 0.5, P < 0.01, Table 3), with 5 patients (38%) reporting symptom improvement (4 moderately better; 1 somewhat better), and 8 with little (n = 1) or no (n = 7) improvement. Patients with symptom improvement reported symptoms of nausea (3), vomiting (1), and loss of appetite (1) improving the most. The patients with symptom improvement had lower pre-dilation pyloric EndoFLIP distensibility at 30 ml (4.7 ± 0.8 vs 13.2 ± 2.9 mm2/mmHg, P = 0.04), 40 ml (7.2 ± 1.0 vs 13.9 ± 2.1 mm2/mmHg, P = 0.02) and 50 ml (4.9 ± 1.0 vs 10.2 ± 1.9 mm2/mmHg, P = 0.04) than patients with little/no improvement. CONCLUSION: In Gp patients with refractory symptoms after pyloromyotomy/pyloroplasty, pyloric TTS dilation improved symptoms in about a third of the patients. Patients with symptom improvement had lower pre-dilation pyloric EndoFLIP distensibility suggesting incomplete myotomy, pyloric muscle regeneration or pyloric stricture. Pyloric EndoFLIP followed by TTS dilation seems to be a promising treatment for some patients with Gp symptoms refractory to pyloromyotomy/pyloroplasty.Table 1Table 2Table 3

EndoFLIP and Pyloric Dilation for Gastroparesis Symptoms Refractory to Pyloromyotomy/Pyloroplasty

Gastroparesis patients may undergo pyloromyotomy/pyloroplasty for chronic refractory symptoms. However, some patients have persistent symptoms. It is unknown if balloon dilation may improve their symptoms. We aimed to (1) assess if pyloric through-the-scope (TTS) balloon dilation results in symptom improvement in gastroparesis patients with suboptimal response to pyloromyotomy/pyloroplasty and (2) determine endoscopic functional luminal imaging probe (EndoFLIP) characteristics of these patients before dilation. Patients with severe gastroparesis refractory to pyloromyotomy/pyloroplasty seen from 2/2019 to 3/2020 underwent pyloric TTS dilation after assessing the pyloric characteristics using EndoFLIP. Patients completed Gastroparesis Cardinal Symptom Index (GCSI) pre-procedurally, and GCSI and Clinical Patient Grading Assessment Scale (CPGAS) on follow-ups. Thirteen (ten females) patients (mean age 45.2 ± 5.1years) with severe gastroparesis symptoms (mean GCSI total score 3.4 ± 0.3) after pyloromyotomy/pyloroplasty underwent pyloric TTS dilation. Overall, there was improvement in symptoms at 1-month follow-up (mean GCSI total score 3.0 ± 0.4, mean CPGAS score 1.6 ± 0.5, p < 0.05 for both), with five (38%) patients reporting symptoms somewhat/moderately better. The patients with symptom improvement had lower pre-dilation pyloric EndoFLIP distensibility at 30ml, 40ml, and 50ml than patients with little/no improvement (all p < 0.05). In gastroparesis patients with refractory symptoms after pyloromyotomy/pyloroplasty, pyloric TTS dilation improved symptoms in about a third of the patients. Patients with symptom improvement had lower pre-dilation pyloric distensibility on EndoFLIP suggesting incomplete myotomy, pyloric muscle regeneration, or pyloric stricture. Pyloric EndoFLIP followed by TTS dilation seems to be a promising treatment for some patients with gastroparesis symptoms refractory to pyloromyotomy/pyloroplasty.

Long-term Outcome of Gastric Per-Oral Endoscopic Pyloromyotomy in Treatment of Gastroparesis

Gastric per oral endoscopic pyloromyotomy (GPOEM) is a promising treatment for gastroparesis. There are few data on the long-term outcomes of this procedure. We investigated long-term outcomes of GPOEM treatment of patients with refractory gastroparesis. We conducted a retrospective case-series study of all patients who underwent GPOEM for refractory gastroparesis at a single center (n = 97), from June 2015 through March 2019; 90 patients had more than 3 months follow-up data and were included in our final analysis. We collected data on gastroparesis cardinal symptom index (GCSI) scores (measurements of postprandial fullness or early satiety, nausea and vomiting, and bloating) and SF-36 questionnaire scores (measures quality of life). The primary outcome was clinical response to GPOEM, defined as a decrease of at least 1 point in the average total GCSI score with more than a 25% decrease in at least 2 subscales of cardinal symptoms. Recurrence was defined as a return to baseline GCSI or GCSI scores of 3 or more for at least 2 months after an initial complete response. The secondary outcome was the factors that predict GPOEM failure (no response or gastroparesis recurrence within 6 months). At initial follow-up (3 to 6 months after GPOEM), 73 patients (81.1%) had a clinical response and significant increases in SF-36 questionnaire scores (indicating increased quality of life) whereas 17 patients (18.9%) had no response. Six months after GPOEM, 7.1% had recurrence. At 12 months, 8.3% of patients remaining in the study had recurrence. At 24 months, 4.8% of patients remaining in the study had a recurrence. At 36 months, 14.3% of patients remaining in the study had recurrence. For patients who experienced an initial clinical response, the rate of loss of that response per year was 12.9%. In the univariate and multivariate regression analysis, a longer duration of gastroparesis reduced the odds of response to GPOEM (odds ratio [OR], 0.092; 95% CI, 1.04-1.3; P = .001). On multivariate logistic regression, patients with high BMIs had increased odds of GPOEM failure (OR, 1.097; 95% CI, 1.022-1.176; P = .010) and patients receiving psychiatric medications had a higher risk of GPOEM failure (OR, 1.33; 95% CI, 0.110-1.008; P = .052). In retrospective analysis of 90 patients who underwent GPOEM for refractory gastroparesis, 81.1% had a clinical response at initial follow-up of their procedure. 1 year after GPOEM, 69.1% of all patients had a clinical response and 85.2% of initial responders maintained a clinical response. Patients maintained a clinical response and improved quality of life for as long as 3 years after the procedure. High BMI and long duration gastroparesis were associated with failure of GPOEM.

Reflux Symptoms in Gastroparesis: Correlation With Gastroparesis Symptoms, Gastric Emptying, and Esophageal Function Testing.

The goal of this study was to determine the relationship of reflux with gastroparesis (Gp), looking both at symptoms and objective testing. Gp patients often experience gastroesophageal reflux symptoms. How the severity of reflux correlates with the severity of Gp is not known. Patients referred to our academic center with symptoms of Gp completed the Patient Assessment of Upper Gastrointestinal Symptoms, Hospital Anxiety and Depression Scale, and Patient Health Questionnaire (PHQ)-15. They underwent 4-hour gastric emptying scintigraphy; and, if indicated, high-resolution esophageal manometry and esophageal pH impedance (EpHI). Of 755 patients from July 2013 to May 2018, 432 had Gp with Gastroparesis Cardinal Symptom Index (GCSI) total score of 3.2±0.1 (mean±SEM) and heartburn/regurgitation subscore of 2.0±0.1. A fourth (27.1%) of all Gp patients had moderate to very severe heartburn/regurgitation symptoms. Heartburn/regurgitation subscore had strong correlation with GSCI total score (r=0.56, P<0.01), and weak correlation with 4-hour gastric retention (r=0.11, P=0.02). In total, 103 Gp patients underwent EpHI monitoring; time esophageal pH<4 had no correlation with heartburn/regurgitation subscore. Less than half (41.7%) of the patients undergoing EpHI had gastroesophageal reflux disease by EpHI. Gp patients with gastroesophageal reflux disease had more severe 4-hour gastric retention, and more frequently had decreased lower esophageal sphincter resting pressure and esophageal motility disorders. Heartburn/regurgitation subscore had moderate correlation with somatic symptoms, and weak correlations with anxiety and depression. The severity of reflux symptoms in Gp has strong correlation with GCSI total score, weak correlation with gastric retention, and no correlation with esophageal pH monitoring.

Symptoms Suggestive of Gastroparesis in a Community-Based Cohort of European Americans and African Americans with Type 2 Diabetes Mellitus.

Although gastroparesis is seen in patients with type 2 diabetes mellitus (T2DM), the prevalence of symptoms suggestive of gastroparesis in patients with T2DM is unknown, particularly among African Americans. To determine the prevalence of symptoms associated with gastroparesis in a large community-based population of European Americans and African Americans with T2DM. Individuals with T2DM in the Diabetes Heart Study were asked to complete the gastroparesis cardinal symptom index (GCSI) and other GI-related questionnaires. GCSI total score ≥ 18 represented moderate or worse symptoms suggestive of gastroparesis. A total of 1253 participants (700 female, 553 male) completed the GCSI: 750 were European American and 503 African American. GCSI scores ≥ 18 were recorded in 72 participants: 38 (5%) of European Americans and 34 (7%) of African Americans. The average GCSI was 24.1 in European Americans and 24.6 in African Americans, indicating moderate to severe symptoms. Compared to European Americans with GCSI scores ≥ 18, African Americans were younger (59.4 vs. 53.3years, p = 0.004), had earlier onset of T2DM (46.3 vs. 40.1years, p = 0.01), higher HbA1c (7.6 vs. 9.1, p = 0.0009), underwent fewer upper endoscopies (55.3% vs. 26.5%, p = 0.02), and had more anxiety and depression (p < 0.001). Moderate or greater symptoms suggestive of gastroparesis are present in 5-7% of European and African American patients with T2DM in community-based populations. Symptoms suggestive of gastroparesis may be underappreciated in patients with T2DM and account for upper gastrointestinal symptoms, unexplained glycemic control issues, and decreased quality of life.

1238 Tradipitant Complete Responder Analysis in Gastroparesis Patients

INTRODUCTION: A Phase II multicenter, randomized, double-blind, placebo-controlled trial with gastroparesis subjects demonstrating delayed gastric emptying and moderate to severe nausea were randomized to receive oral 85 mg tradipitant bid or placebo (1:1) for four weeks. Of the 152 patients enrolled, 60% of patients had idiopathic and 40% had diabetic gastroparesis. METHODS: The primary outcome was change in average nausea score from baseline, measured using the 5-point Gastroparesis Core Symptom Daily Diary (GCSDD). Overall gastroparesis symptoms were evaluated using the Gastroparesis Cardinal Symptom Index (GCSI), and Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM). RESULTS: A statistically significant and clinically meaningful improvement in nausea and overall gastroparesis symptoms was observed in patients on tradipitant. Subjects receiving tradipitant had a significant decrease in their average nausea score compared to placebo with LS mean difference (95% CI) of -0.53 (-0.92, -0.13, P = 0.0099) as well as a significant increase in nausea free days (28.8% increase on tradipitant compared to 15.0% increase on placebo, P = 0.0160). A complete nausea response as defined by a nausea severity score ≤1 at week 4 was found to occur in 33% of patients on tradipitant compared to 12% of patients on placebo (P = 0.0013). A clinically meaningful response in overall gastroparesis defined as a 1-point or more improvement on the GCSI total score was observed in 46.6% of patients on tradipitant compared to 23.5% of patients on placebo (P = 0.0053). CONCLUSION: Tradipitant treatment resulted in statistically and clinically meaningful improvements in nausea and overall gastroparesis symptoms. Tradipitant was well tolerated with comparable rates of adverse events between tradipitant and placebo groups. These robust efficacy results suggest tradipitant has the potential to become a first line pharmacological treatment for gastroparesis.

Surgical Treatment for Refractory Gastroparesis: Stimulator, Pyloric Surgery, or Both?

BackgroundSeveral surgical options exist for refractory gastroparesis (Gp) including gastric electric stimulation (GES) and pyloric surgery (PS) such as pyloromyotomy or pyloroplasty. Few studies exist comparing the outcomes of these surgeries. AimCompare the clinical outcomes of GES, PS, and simultaneous GES+PS for refractory Gp. MethodsPatients undergoing surgical intervention at our medical center from January 2016 to April 2019 were given pre- and post-surgery questionnaires to assess their response to intervention: Patient Assessment of Upper Gastrointestinal Symptoms (PAGI-SYM) grading symptoms and Clinical Patient Grading Assessment Scale (CPGAS) grading response to treatment. Results are expressed as mean ± SE. ResultsOne hundred thirty-two patients underwent surgical intervention; 12 were excluded. Mean CPGAS improvement overall was 2.8±0.2 (p < 0.01): GES+PS had CPGAS score at 3.6 ± 0.5, pyloric interventions 3.1 ± 0.5, and GES 2.5±0.4 (p > 0.05). Mean improvement in Gastroparesis Cardinal Symptom Index (GCSI) total score was 1.0±0.1 (p < 0.01), with improvement of 1.1±0.2 for GES + PS, 0.9±0.2 for GES, and 0.9±0.2 for PS (p > 0.05). GES and GES + PS, but not PS only, significantly improved symptoms of nausea and vomiting (p < 0.01). Among gastroparesis subtypes, patients with diabetic gastroparesis had more improvement on nausea/vomiting subscale compared with idiopathic gastroparesis (p = 0.028). ConclusionsPatients with refractory symptoms of Gp undergoing GES, PS, or combined GES+PS each had significant improvement of their GCSI total score. GES and combined GES+PS significantly improved nausea/vomiting. These results suggest GES or combined GES+PS appears better for nausea/vomiting predominant refractory Gp.

Caregiver Burden in Gastroparesis and GERD: Correlation with Disease Severity, Healthcare Utilization and Work Productivity.

Caregiver burden can be significant in chronic gastrointestinal diseases. No studies have been performed to evaluate caregiver burden in gastroparesis or gastroesophageal reflux disease (GERD). (1) Assess the caregiver burden in gastroparesis and GERD patients and healthy volunteers (HVs); (2) correlate the caregiver burden of these patients to the severity of patients' symptoms, healthcare utilization, and work productivity of the patients and the caregivers. Patients with gastroparesis and GERD, seen between June 2018 and November 2018, completed Patient Assessment of Gastrointestinal Symptoms, Work Productivity and Activity Impairment (WPAI) and healthcare utilization questionnaires. The caregivers of these patients completed Zarit Burden Interview (ZBI) and WPAI questionnaire. HVs and their potential caregivers also completed these questionnaires. Forty-seven patients (gastroparesis = 31, GERD = 17), 12 HVs, and their caregivers completed questionnaires. Caregivers of gastroparesis patients reported high burden on ZBI (27.7 ± 2.9), greater than the caregivers of GERD (14.9 ± 2.5) and HVs (5.5 ± 1.6, p < 0.01). Among all patients, the caregiver burden had a strong correlation with patients' Gastroparesis Cardinal Symptom Index (GCSI) total score (rs = 0.63, p < 0.01) and moderate correlations with the number of patients' physician office visits (rs = 0.46, p < 0.01) and the number of work hours missed by caregivers due to patients' symptoms (rs = 0.36, p = 0.04). Using multivariable regression, both presence of gastroparesis and other comorbidities significantly predicted caregiver burden, F(2, 33) = 15.94, p < 0.0001, R2 = 0.491. Caregivers of gastroparesis patients have high caregiver burden that strongly correlates with patients' GCSI total score. Interventions to reduce symptom severity of Gp patients may reduce the caregiver burden.

34-LB: Clinically Meaningful Improvements of Gastroparesis Overall Symptoms Using Tradipitant

Background: Patients with diabetic and idiopathic gastroparesis with delayed gastric emptying and moderate to severe nausea were enrolled into a phase II multicenter, randomized, double-blind, placebo-controlled trial. Subjects were randomized to receive oral 85mg tradipitant bid or placebo (1:1) for 4 weeks. Of the 152 patients, 60% of patients had idiopathic and 40% had diabetic gastroparesis. Methods: The primary outcome was change in average nausea from baseline, measured using the 5-point Gastroparesis Core Symptom Daily Diary (GCSDD). Overall gastroparesis symptoms were evaluated using the Gastroparesis Cardinal Symptom Index (GCSI), and Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM). Results: A statistically significant and clinically meaningful improvement in nausea and overall gastroparesis symptoms was observed in patients on tradipitant. Subjects receiving tradipitant had a significant decrease in their average nausea score compared to placebo with LS mean difference (95% CI) of -0.53 (-0.92, -0.13, p=0.0099) as well as a significant increase in nausea free days (28.8% increase on tradipitant compared to 15.0% increase on placebo, p=0.0160). A clinically meaningful response of 1-point or more improvement on the GCSI total score was observed in 46.0% of patients on tradipitant compared to 24.2% of patients on placebo (p=0.0086). Conclusions: Tradipitant treatment resulted in statistically and clinically meaningful improvements in nausea and overall gastroparesis symptoms. Tradipitant was well tolerated with comparable rates of adverse events between tradipitant and placebo groups. These robust efficacy results suggest tradipitant has the potential to become a first line treatment for idiopathic and diabetic gastroparesis. Disclosure J.L. Carlin: Employee; Self; Vanda Pharmaceuticals, Inc. V.R. Lieberman: Employee; Self; Vanda Pharmaceuticals, Inc. Stock/Shareholder; Self; Vanda Pharmaceuticals, Inc. A. Dahal: Employee; Self; Vanda Pharmaceuticals, Inc. Stock/Shareholder; Self; Vanda Pharmaceuticals, Inc. M.S. Keefe: Employee; Self; Vanda Pharmaceuticals. Stock/Shareholder; Self; Vanda Pharmaceuticals. C. Xiao: Employee; Self; Vanda pharmaceutical inc. G. Birznieks: Employee; Self; Vanda Pharmaceuticals. M.H. Polymeropoulos: Employee; Self; Vanda Pharmaceuticals Inc.

Functional Dyspepsia: Clinical Symptoms, Psychological Findings, and GCSI Scores.

The GCSI questionnaire measures symptoms of gastroparesis (GP). Symptoms of FD overlap with GP. The ability of the GCSI to discriminate FD from GP is unknown. By prospectively evaluating functional dyspepsia (FD) patients, we aimed to evaluate the ability of the Gastroparesis Cardinal Symptom Index (GCSI) to: (1) distinguish FD from GP; (2) predict symptom severity, anxiety, and depression; (3) correlate symptoms with gastric emptying. FD patients (Rome III criteria) were identified, and upper endoscopy and gastric emptying scan (GES) data recorded. A total of 254 patients were mailed a questionnaire evaluating demographics, FD symptoms, mental well-being; the GCSI was included. One hundred and twenty-three patients responded; of them, 75% were women and mean age was 49 (15 SD) years. 44.7% were categorized as postprandial distress subtype (PDS), 34.1% were epigastric pain subtype (EPS), and 21.1% were mixed type. The mean GCSI score was 2.02 (1.1 SD), slightly lower than historical GP controls (2.26-2.56). Mixed EPS-PDS subtype had the lowest GCSI scores (1.79; 0.91 SD). Bloating was the highest GCSI subscore (2.70; 1.53 SD), followed by fullness (2.31; 1.39 SD) and nausea (1.08; 1.19 SD). The GCSI total score did not correlate with anxiety and depression scores or with 4-h gastric emptying. In this population of FD patients, GCSI scores were slightly lower than historical gastroparesis control patients, although within the reported range. These results suggest that the GCSI cannot accurately distinguish FD patients from GP patients. A more specific questionnaire is needed to aid in the diagnosis and management of these distinct gastrointestinal disorders.

Regional gastrointestinal pH profile is altered in patients with type 1 diabetes and peripheral neuropathy.

Gastrointestinal (GI) symptoms, such as nausea and bloating, are common in people with type 1 diabetes (T1DM). Autonomic dysfunction can lead to changes in the GI secreto-motor function which can be associated with GI symptom development. We hypothesized that regional pH profiles in T1DM differs from health and would be associated with objective physiological/clinical markers. Forty-seven T1DM with confirmed diabetic sensory peripheral neuropathy and 41 healthy age-matched subjects underwent standardized wireless motility capsule testing. T1DM completed the gastroparesis cardinal symptom index (GCSI) and the gastrointestinal symptom rating scale. Disease duration, glycemic control, insulin usage, and 24-hour heart rate variability testing were evaluated. In comparison to healthy subjects, gastric, and large bowel median pH were lower in T1DM (1.8±1.6 vs 2.9±1.5, P=0.001 and 6.7±0.6 vs 7.0±0.5, P=0.003, respectively). Additionally, change in pH across the pylorus was lower while change in pH across the ileocecal junction was higher in T1DM (5.2±1.5 vs 5.8±0.5, P=0.003 and 1.8±0.4 vs 1.3±0.4, P<0.0001, respectively). No difference was found in small bowel median pH. Gastric median pH was associated with small bowel transit time (r=0.30, P=0.049). Change in pH across the pylorus was negatively associated with fasting glycose (r=-0.35, P=0.027). Small bowel median pH was associated with nausea (r=0.42, P=0.005) and small bowel transit time (r=0.48, P=0.0007). Large bowel median pH was associated with nausea (r=0.35, P=0.018) and the total GCSI score (r=0.34, P=0.023). The GI pH profile in T1DM with DSPN is different from healthy subjects. Changes in pH profile may have important therapeutic implications and influence pharmacotherapeutic bioavailability.

Effect of Intravenous Fluids and Analgesia on Dysmotility in Patients With Acute Pancreatitis: A Prospective Cohort Study.

Analgesia and intravenous fluid resuscitation are cornerstones of initial patient management in acute pancreatitis (AP). The aim was to investigate the effect of intravenous fluids and analgesia on gastrointestinal motility in the early course of AP. Gastrointestinal dysmotility was assessed using the Gastroparesis Cardinal Symptom Index (GCSI). One-way analysis of variance and analysis of covariance were conducted, adjusting for age, sex, body mass index, severity of AP, preexisting diabetes mellitus, and time from first symptom onset to hospital admission. A total of 108 patients with AP were prospectively enrolled. Opioid analgesia, when compared with nonopioid analgesia, was significantly associated with increase in total GCSI score in both unadjusted and adjusted analyses. There was no significant difference between aggressive and nonaggressive fluid resuscitation in both unadjusted and adjusted analyses. A combination of opioids and any intravenous fluids was associated with a significantly increased total GCSI score compared with opioids and no intravenous fluids in both unadjusted and adjusted analyses. Duration of symptoms was the confounder that significantly affected 6 of 9 studied associations. Intravenous fluids and analgesia significantly affect motility independent of severity and other covariates. Guidelines on prudent use of opioids and fluids in AP need to be developed, particularly taking into account duration of symptoms from onset to hospitalization.

Nomogram for predicting oral feeding intolerance in patients with acute pancreatitis

ObjectivesOral feeding intolerance (OFI) is a common complication of acute pancreatitis that leads to prolonged hospitalization, increased use of hospital resources, and impaired quality of life. However, there are no clinically useful predictors of OFI. The aims of this study were to determine whether gastrointestinal dysmotility is associated with the development of OFI, and whether the gastroparesis cardinal symptom index (GCSI) can be used as a predictive tool in a clinical setting. MethodsThis was a prospective cohort study. The primary outcome was the development of OFI. Daily GCSI total score and subscores (nausea/vomiting, early satiety, and bloating) were recorded. Univariate and multivariate binary logistic regression analyses were conducted, adjusting for age, etiology of pancreatitis, severity, diabetes status, and time from symptom onset to hospital admission. ResultsThe study included 217 consecutive adult patients with acute pancreatitis. Multivariate analyses showed significant associations between OFI occurrence and the total GCSI score on day 2 of hospital admission (odds ratio [OR], 1.42; 95% confidence interval [CI], 1.02–2.00), the highest total GCSI score (OR, 1.38; 95% CI, 1.03–1.86), the day 2 nausea/vomiting subscore (OR, 1.40; 95% CI, 1.04–1.89), the day 2 bloating subscore (OR, 1.25; 95% CI, 1.01–1.54), and the highest bloating subscore (OR, 1.32; 95% CI, 1.08–1.63). ConclusionsGastrointestinal dysmotility is associated with the development of OFI and the GCSI has potential as a clinically useful predictive tool in the setting of acute pancreatitis. The developed nomogram holds promise but needs to be validated externally.

Effect of Nasogastric Tube Feeding vs Nil per Os on Dysmotility in Acute Pancreatitis: Results of a Randomized Controlled Trial.

Evidence from animal studies suggests that gastrointestinal motility is impaired in acute pancreatitis. Enteral nutrition, and more specifically nasogastric tube feeding, has emerged as a key treatment modality in patients with acute pancreatitis, but its effect on motility has not been investigated in this setting. The aim was to validate the Gastroparesis Cardinal Symptom Index (GCSI) in patients with acute pancreatitis and determine the effect of nasogastric tube feeding on GCSI. The study design was a randomized controlled trial. Patients were allocated to nasogastric tube feeding or nil per os within 24 hours of hospital admission. GCSI data from before randomization to 72 hours after randomization were analyzed. The test-retest reliability analysis was used to calculate Cronbach's α. Seventeen patients were randomized to nasogastric tube feeding and 18 to nil per os. Overall, the total GCSI score significantly decreased over the study (F = 8.537; P = .001) but was not significantly different between the 2 study groups during hospitalization (F = 1.159; P = .322). However, patients on nasogastric tube feeding did show improved appetite compared with nil per os (F = 3.526; P = .036). The GCSI was found to be a reliable tool in the setting of acute pancreatitis (Cronbach's α = 0.852). Nasogastric tube feeding does not appear to affect dysmotility symptoms in acute pancreatitis as measured by the GCSI, although appetite improved. Use of the simple, noninvasive, and inexpensive GCSI tool to evaluate motility is recommended in future clinical trials in pancreatology.

PTU-174 Can gastroparesis cardinal symptom index (GCSI) sub-scores and total score predict delayed gastric emptying?

Introduction The Gastroparesis Cardinal Symptom Index (GCSI) is a validated tool for monitoring treatment induced changes in the symptoms of gastroparesis. For diagnosis, a gastric emptying scintigraphy (GES) study must be done to demonstrate the delayed gastric emptying (DGE) that separates gastroparesis from its functional differentials. Previous studies noted associations between GES results and GCSI values but these were not sufficiently predictive to allow reliable diagnosis. This study aimed to corroborate these findings. If GCSI could be proved to be predictive of DGE, it may allow for less GES studies, especially as part of follow up, resulting in reduced costs and less radiation exposure for the patient. Method Forty one patients with symptoms suggestive of gastroparesis were identified at clinic. Patients filled out the GCSI questionnaire and underwent a GES study as part of standard investigation of their symptoms. Linear regressions were used to identify if the GCSI sub-scores or the total GCSI score were predictive of% gastric retention across all imaging times. Mann-Whitney U tests were used to identify any significant differences between the distributions of the GCSI components in those with DGE and those without. Both tests were done for the whole population, then for the three main aetiologies (idiopathic, diabetes mellitus, post-surgical). Results For the whole population, regression analysis identified three components as positive predictors at 2 hrs (total GCSI score, post-prandial fullness and bloating sub-scores). The R2values were all ≤0.16 and the only significant Mann-Whitney U test was for the total GCSI score. For idiopathic cases there was only one significant positive predictor, again at 2 hrs (total GCSI score, R2= 0.244). There were significant differences in the distributions of the average score and the nausea and vomiting sub-score. Post-operative cases had five significant negative predictors: nausea and vomiting sub-score (R2= 0.389) at ½ hr; nausea and vomiting sub-score (R2= 0.547), total GCSI score (R2= 0.428), bloating sub-score (R2= 0.364) at 1 hr; nausea and vomiting sub-score at 4 hrs (R2= 0.468). All of these components had associated significant Mann-Whitney U tests. There were no significant Mann-Whitney U tests in the diabetic cohort, but there were three significant positive predictors: bloating sub-score at 1 hr (R2= 0.577) and 2 hrs (R2= 0.590), post-prandial fullness sub-score at 2 hrs (R2= 0.612). Conclusion All GCSI components studied were associated with significant linear regression findings but their individual predictive power tends to be poor. Thus, it is unlikely the GCSI components in isolation would be clinically useful as diagnostic predictors of gastroparesis. This concurs with the conclusions of previous studies in this field. Disclosure of interest None Declared.

Duodenal Rather Than Gastric Motility Parameters Correlate With Symptom Severity in Patients With Diabetic Gastroparesis

Introduction: Gastroparesis symptom severity correlates poorly with rate of gastric emptying. Previously, we showed that duodenal contractility correlated better than gastric motility with symptoms (Barshop K, DDW 2014). To confirm these findings, we assessed the correlation of contractility with gastroparesis symptoms in patients taking the investigational motilin agonist camicinal (C) or placebo, using wireless motility capsule (WMC). The design, primary efficacy, and safety results of this study have been previously reported (Barton ME, DDW 2014). Patients receiving C 10 mg or 50 mg showed improvement in symptoms vs. placebo;125 mg did not. Methods: Diabetics with gastroparesis (confirmed by 13 C oral breath test) with at least moderate symptoms were enrolled in a double blind randomized study of placebo, 10, 50, or 125 mg doses of C daily for 28 days. The 3 dosage groups were combined for analyses. Symptom severity assessed by Gastroparesis Cardinal Symptom Index (GCSI) was averaged for the first 7 days of treatment. Gut contractility was assessed on day 1, 90 minutes following the initial dose. The frequency of contractions (CT), area under pressure curve (AUC), and motility index (MI) were analyzed in the 1-hour period prior to (antral [A] window) and post (duodenal [D] window) WMC gastric emptying (GET). Results: Seventy-nine subjects were enrolled. The most common investigator assessed drug-related AEs were headache, UTI, and GI symptoms, generally similar in frequency across treatment groups. There were no study withdrawals due to AEs, nor any drug-related serious AEs. Gut contractility parameters poorly correlated with symptom severity for the treatment cohort (n=51; r<0.14) and placebo cohort (n=10; r<0.26) in either A or D windows. The subgroup of subjects (n=14) with delayed gastric emptying (WMC GET>5 hrs) treated with C showed moderate correlations in the D window between postprandial fullness and CT, AUC, and MI (r= -0.43, -0.51, -0.45; p>0.12). Symptom improvement was observed at the 2 lower doses (10 and 50 mg) of C. Further analysis was conducted with these treatment groups (n=10). Small bowel CT correlated moderately with GCSI total score (r= -0.76; p=0.01), bloating (r= -0.72; p=0.02), and postprandial fullness (r= -0.84; p<0.01). Weak correlations between symptoms and gastric contractility were observed even with the sample limited to gastroparetics and the 125-mg dose group removed. Conclusion: Data suggests duodenal contractile parameters moderately correlated with gastroparesis symptoms in patients with delayed gastric emptying treated with a motilin agonist. The correlation of symptoms with duodenal motility was strongest with doses where patients reported symptomatic improvement. Disclosure - George Dukes - Employee, GSK. Matthew Barton - Employee, GSK. Kenneth Barshop - none. Braden Kuo - Consultant, GSK. Jack Semler - Consultant, GSK, GivenImaging. This research was supported by an industry grant from GlaxoSmithKline(GSK).

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.