Total Gastroparesis Cardinal Symptom Index 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.

A Randomized, Controlled Trial of Efficacy and Safety of Cannabidiol in Idiopathic and Diabetic Gastroparesis

Cannabis (delta-9-tetrahydrocannabinol), a nonselective cannabinoid-receptor agonist, relieves nausea and pain. Cannabidiol (CBD), a cannabinoid receptor 2 inverse agonist with central effects, also reduces gut sensation and inflammation. We compared the effects of 4 weeks of treatment with pharmaceutical CBD vs placebo in patients with idiopathic or diabetic (diabetes mellitus) gastroparesis. We performed a randomized, double-blinded, placebo-controlled study of CBD twice daily (Epidiolex escalated to 20 mg/kg/d; Jazz Pharmaceuticals, Dublin, Ireland) in patients with nonsurgical gastroparesis with delayed gastric emptying of solids (GES). Symptoms were assessed by the Gastroparesis Cardinal Symptom Index Daily Diary. After 4 weeks of treatment, we measured GES, gastric volumes, and Ensure (Abbott Laboratories, Abbott Park, IL) satiation test (1 kcal/mL, 30 mL/min) to assess volume to comfortable fullness and maximum tolerance. Patients underwent specific FAAH and CNR1 genotyping. Statistical analysis compared 2 treatments using analysis of variance including baseline measurements and body mass index as covariates. Among 44 patients (32 idiopathic, 6 diabetes mellitus type 1, and 6 diabetes mellitus type 2), 5 patients did not tolerate full-dose escalation; 3 withdrew before completing 4 weeks of treatment (2 placebo, 1 CBD); 95% completed 4 weeks of treatment and diaries. Compared with placebo, CBD reduced the total Gastroparesis Cardinal Symptom Index score (P= .008), inability to finish a normal-sized meal (P= .029), number of vomiting episodes/24 hours (P= .006), and overall symptom severity (P= .034). Patients treated with CBD had a higher volume to comfortable fullness and maximum tolerance and slower GES. FAAH rs34420 genotype significantly impacted nutrient drink ingestion. The most common adverse events reported were diarrhea (14 patients), fatigue (8 patients), headache (8 patients), and nausea (7 patients). CBD provides symptom relief in patients with gastroparesis and improves the tolerance of liquid nutrient intake, despite slowing of GES. gov NCT #03941288.

Gastroparesis with concomitant gastrointestinal dysmotility is not a contraindication for per-oral pyloromyotomy (POP).

Per-oral pyloromyotomy (POP or G-POEM) provides significant short-term improvements in symptoms and objective emptying for patients with medically refractory gastroparesis, but it is unclear if patients with gastroparesis and co-existing dysmotility (small bowel or colonic delay) also benefit. In this study, we used wireless motility capsule (WMC) data to measure outcomes in patients with isolated gastroparesis (GP) and gastroparesis with co-existing dysmotility (GP + Dys) who underwent POP. We retrospectively analyzed patients who had POP and completed WMC data during their evaluation of intestinal dysmotility. WMC data were reviewed to identify patients who demonstrated isolated GP or GP + Dys. Each patient's pre-op and post-op Gastroparesis Cardinal Symptom Index (GCSI) and 4-h solid-phase scintigraphy gastric emptying studies (GES) scores were compared to evaluate improvement. Of the entire cohort (n = 73), 89% were female with a mean age of 47.0 ± 15.0years old. Gastroparesis etiologies were divided among idiopathic (54.8%), diabetic (26%), postsurgical (8.2%), autoimmune (5.5%), and multifactorial (5.5%).Forty-one patients (56%) had GP and 32 patients (44%) had GP + Dys. GCSI improved after POP whether the patient had isolated GP (- 12.31, p < 0.001) or GP + Dys (- 9.58, p < 0.001); however, there was no significant difference in total GCSI improvement between the two groups. A subset of patients had postoperative GES available (n = 47). In the isolated GP and GP + Dys cohorts, 15/28 (54%) and 12/19 (63%) patients had normal post-op 4-h GES, respectively, but no statistical difference between the two groups. Patients with medically refractory gastroparesis with and without concomitant gastrointestinal dysmotility show short-term subjective and objective improvement after POP. Concomitant small bowel or colonic dysmotility should not deter physicians from offering POP in carefully selected patients with gastroparesis.

Beyond Metoclopramide for Gastroparesis

Beyond Metoclopramide for Gastroparesis

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.

Gastric Peroral Endoscopic Myotomy: A Specific Learning Curve.

Gastric peroral endoscopic pyloromyotomy (G-POEM) is a novel option for patients with gastroparesis. It involves submucosal tunneling across the pylorus, followed by pyloromyotomy, and subsequent closure of the endoscopic tunnel. The aim of this study was to determine the learning curve for G-POEM. Consecutive patients undergoing G-POEM by a single operator were included from a prospective registry over 2 years. Demographics, procedure info, postprocedure follow-up data, and adverse events were collected. Nonlinear regression and cumulative sum control chart analyses were conducted for the learning curve. Clinical outcomes were improvement in Gastroparesis Cardinal Symptom Index score and gastric emptying scintigraphy. Thirty-six patients were included (16.7% M, mean age 46 y). The majority had idiopathic gastroparesis (n=16, 44%), with the remaining having diabetes (n=5, 17%), postsurgical (n=10, 28%), or other (n=4, 11%). Technical success was achieved in 35 of 36 (97%). There was a significant reduction in the total Gastroparesis Cardinal Symptom Index score (2.09 units, P<0.00001) and a significant reduction in postoperative gastric emptying scintigraphy (82.44 mins, P<0.00001). Mean follow-up was 15 months (SD, 1.05). Median procedure time was 60.5 minutes (range, 35 to 136). Cumulative sum control chart shows 60-minute procedure was achieved at the 18th procedure. Procedure durations further reduced with consequent procedures with the last 3 being 45 minutes, thus demonstrating continued improvement with ongoing experience (nonlinear regression P<0.0001). Endoscopists experienced in G-POEM are expected to achieve a reduction in procedure time over successive cases, with efficiency reached at 60.5 minutes and a learning rate of 18 cases with continuing improvement.

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.

S0951 Effect of Opiate Usage on Patient Outcomes After Gastric Per-Oral Endoscopic Pyloromyotomy (GPOEM) for Refractory Gastroparesis

INTRODUCTION: Chronic opioid use is prevalent in patients with gastroparesis and has been associated with more severe gastrointestinal symptoms and increased healthcare utilization. GPOEM has gained recognition as an effective endoscopic therapy for treatment of refractory gastroparesis. Currently there is limited knowledge of the effect of opiate use in patients undergoing GPOEM. METHODS: We performed a single-center retrospective study of patients who underwent GPOEM for refractory gastroparesis. Patients were stratified into two groups: 1) patients on chronic opiates prior to or after GPOEM and 2) patients who were not on chronic opiates prior to or after GPOEM. Primary outcomes included gastric emptying study results pre- and post-GPOEM and symptom response pre- and post-GPOEM as measured by the Gastroparesis Cardinal Symptom Index (GCSI), a validated nine-item questionnaire with 3 subscores that rate symptom severity from absent (0) to severe (5). Univariate statistical analysis was performed using t-test (SAS, version 9.4). RESULTS: 22 patients underwent GPOEM from 2017 to 2019. Nine (41%) patients were prescribed chronic opiates both prior to and after GPOEM, while 13 (59%) patients did not have chronic opiate prescriptions before and after GPOEM. The etiology of gastroparesis was predominantly post-surgical, accounting for 7 (78%) patients on opiates and 8 (62%) of patients without opiates. Mean follow-up time for all patients after GPOEM was 8.21 ± 4.6 months. Opiate users had higher baseline and post-GPOEM four-hour residuals on GES compared to patients without opiate use (baseline: 59.3% vs 43%, P = 0.18; post-GPOEM: 40.3% vs 19.7%, P = 0.27). Mean total GCSI prior to GPOEM was not significantly different between opiate and non-opiate users (3.24 vs 3.01, P = 0.63). Non-opiate users had significantly lower mean total GCSI after GPOEM compared to patients on opiates (1.32 vs 2.32, P < 0.05), as well as significantly greater overall improvement in GCSI. (56% vs 17%, P < 0.05). CONCLUSION: Non-opiate users appear to respond more favorably to GPOEM as characterized by significantly greater improvements in GCSI scores, and significantly lower overall GCSI scores following this intervention. Multidisciplinary approaches incorporating opioid weaning protocols prior to GPOEM may improve symptom-based outcomes subsequent to this procedure.Table 1.: Clinical Characteristics of Patients with and without Opiate Use before and after GPOEMFigure 1

Comparative study on effect of electroacupuncture at lower he-sea point of stomach and he-sea matching front-mu points for gastroparesis

To explore the efficacy difference of electroacupuncture at lower he-sea point and he-sea matching front-mu points for the treatment of gastroparesis. A total of 63 patients with gastroparesis were randomly divided into a lower he point group (group A, 32 cases, 2 cases dropped off) and a he matching mu points group (group B, 31 cases, 1 case dropped off). The group A was treated with electroacupuncture at Zusanli (ST 36), and the group B was treated with electroacupuncture at Zusanli (ST 36) and Zhongwan (CV 12). Both groups were treated with continuous wave (2 Hz in frequency) for 30 min, once a day, 5 times a week for 3 weeks. The gastroparesis cardinal symptom index (GCSI) score, gastric half-emptying time (T1/2) and the 180 min gastric residual rate of the two groups before and after treatment were observed, and the clinical effective rate was compared. After treatment, the total GCSI scores, T1/2 and the 180 min gastric residual rates in both groups were lower than those before treatment (P<0.01), and the 180 min gastric residual rate and T1/2 in the group A were lower than those in the group B (P<0.05). The total effective rate was 93.3% (28/30) in the group A, which was superior to 70.0% (21/30) in the group B (P<0.05). Electroacupuncture at lower he-sea point and he-sea matching front-mu points can both be used to treat gastroparesis, but electroacupuncture at Zusanli (ST 36) has a better effect. The acupoints of Zusanli (ST 36) and Zhongwan (CV 12) may have antagonistic effects.

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.

Delayed Gastric Emptying Is Not Associated with a Microbiological Diagnosis of Small Intestinal Bacterial Overgrowth.

Clinical symptoms of patients with small intestinal bacterial overgrowth (SIBO) may overlap with symptoms of gastroparesis. Prior studies suggest delayed small intestinal transit is associated with SIBO, but have not shown an association between delayed gastric emptying and SIBO. However, these studies have generally relied on the indirect method of breath testing to diagnose SIBO. The aim of this study was to examine the association between amicrobiological diagnosis of SIBO and delayed gastric emptying by scintigraphy. In a single-center retrospective study of previous research participants who presented for small bowel enteroscopy for diagnostic evaluation of SIBO, we identified 73 participants who underwent gastric emptying study by scintigraphy. A microbiological diagnosis of SIBO was made in patients based on culture results of jejunal aspirates. Clinical symptoms were assessed using the total gastroparesis cardinal symptom index (GCSI) score. We compared delayed gastric emptying, 2- and 4-h gastric retention, and gastroparesis symptoms between patients with and without a microbiological diagnosis of SIBO. Among 29 participants with SIBO and 44 without SIBO, 33 (45%) had evidence of delayed gastric emptying. There was no significant association between a microbiological diagnosis of SIBO and delayed gastric emptying by scintigraphy. Percent retained at 2 and 4h, and total GCSI scores did not differ significantly between those with and without SIBO. Although delayed gastric emptying is common in patients with suspected SIBO, gastric emptying is not associated with a microbiological diagnosis of SIBO.

Prucalopride in Gastroparesis: A Randomized Placebo-Controlled Crossover Study.

Prokinetics are considered the preferred treatment option for gastroparesis, but evidence of their efficacy is scarce. Prucalopride, a selective 5-hydroxytryptamine 4 receptor agonist used in the treatment of constipation, is able to enhance the gastric emptying rate. In a double-blind, randomized, placebo-controlled crossover study, we evaluated the efficacy of prucalopride to improve the gastric emptying rate and symptoms in patients with gastroparesis. Thirty-four patients with gastroparesis (28 idiopathic, 7 men, mean age 42 ± 13 years) were evaluated in a double-blind crossover trial of 4-week treatment periods with placebo or prucalopride 2 mg q.d., separated by 2 weeks of washout. The primary end point was the change in symptom severity, assessed by the Gastroparesis Cardinal Symptom Index; secondary end points comprised the Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index, the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life, and daily diaries, and the gastric emptying rate was assessed by the C-octanoic acid breath test. Three patients were lost to follow-up. One serious adverse event occurred (small bowel volvulus in the prucalopride group), and 3 patients dropped out because of adverse events of nausea and headache (all prucalopride). For the entire patient group, compared with placebo, prucalopride significantly improved the total Gastroparesis Cardinal Symptom Index (1.65 ± 0.19 vs 2.28 ± 0.20, P < 0.0001) and the subscales of fullness/satiety, nausea/vomiting, and bloating/distention. Prucalopride significantly improved the overall Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life score (1.15 ± 0.16 vs 1.44 ± 0.16, P < 0.05) and the domains of clothing and diet. The gastric half emptying time was significantly enhanced by prucalopride compared with placebo and baseline (98 ± 10 vs 143 ± 11 and 126 ± 13 minutes, P = 0.005 and <0.001, respectively). These significant improvements were also found when considering only the idiopathic gastroparesis subgroup. In a cohort of patients with predominantly idiopathic gastroparesis, 4 weeks of prucalopride treatment significantly improved symptoms and quality of life and enhanced gastric emptying compared with placebo.

Spatial Patterns From High-Resolution Electrogastrography Correlate With Severity of Symptoms in Patients With Functional Dyspepsia and Gastroparesis

Invasive gastric electrical mapping has revealed spatial abnormalities of the slow wave in subjects with gastroparesis and functional gastrointestinal disorders. Cutaneous high-resolution electrogastrography (HR-EGG) is a non-invasive method that can detect spatial features of the gastric slow wave. We performed HR-EGG in subjects with active foregut symptoms to evaluate associations between gastric myoelectric abnormalities, symptoms (based on a validated questionnaire), and gastric emptying. We performed a case-control study of 32 subjects, including 7 healthy individuals (controls), 7 subjects with functional dyspepsia and normal gastric emptying, and 18 subjects with gastroparesis, from a tertiary care program. All subjects were assessed by computed tomography imaging of the abdomen and HR-EGG and completed the PAGI-SYM questionnaire on foregut symptoms, which includes the gastroparesis cardinal symptom index. We performed volume reconstruction of the torso and stomach from computed tomography images to guide accurate placement of the HR-EGG array. Spatial slow-wave abnormalities were detected in 44% of subjects with foregut symptoms. Moreover, subjects with a higher percentage of slow waves with aberrant propagation direction had a higher total gastroparesis cardinal symptom index score (r= 0.56; P < .001) and more severe abdominal pain (r= 0.46; P= .009). We found no correlation between symptoms and traditional EGG parameters. In case-control study, we found that the genesis of symptoms of functional dyspepsia and gastroparesis is likely multifactorial, including possible contribution from gastric myoelectric dysfunction. Abnormal spatial parameters, detected by cutaneous HR-EGG, correlated with severity of upper gastrointestinal symptoms, regardless of gastric emptying. This noninvasive, repeatable approach might be used to identify patients for whom gastric myoelectric dysfunction contributes to functional dyspepsia and gastroparesis.

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.

Proof of concept: short-term non-invasive cervical vagus nerve stimulation in patients with drug-refractory gastroparesis

BackgroundGastric electric stimulation (GES) is a treatment approach to refractory gastroparesis, possibly acting centrally via afferent vagus nerve stimulation (VNS). Non-invasive VNS (nVNS) is a potential alternative to GES that...

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.

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.