Gastric Emptying Scintigraphy Research Articles

Clinical Relevance of 30-Minute Retention Value in Diagnosing Rapid Gastric Emptying by a Scintigraphic Test

Purpose: Currently, a 60-minute measurement of a standardized gastric emptying scintigraphy (GES) is used for diagnosis of rapid gastric emptying, and shorter intervals such as the 30-minute retention value have not been widely utilized. The purpose of our study is to determine the potential diagnostic power of the percent retention of the study meal at the 30-minute interval. Methods: We retrospectively reviewed 450 results of 4-hour GES test. Among these reports, 320 (71%) were non-delayed, of which 122 (38%) had both a 30-minute and 60-minute retention values recorded. Rapid emptying was defined as <70% retention at 30 minutes or <35% retention at 60 minutes. Statistical analysis using McNemar's test was performed to evaluate the proportion of discordant pairs between these two time intervals, and a p<0.0001 was determined to be significant. Results: Of the 122 non-delayed GES reports with both 30-minute and 60-minute retention values, 42 (34%) were classified as normal at both time points, and 46 (38%) met criteria as rapid at both intervals. Combined, the overall concordance was determined to be 72%. Additionally, 33 (27%) were classified as rapid at 30 minutes, but normal at 60 minutes, and one showed normal value at 30 minutes and rapid at 60 minutes. Among all GES reports, the 30-minute retention value classified 65% of results as rapid whereas only 38% of this group were classified as rapid at 60 minutes. Using McNemar's test, the proportion of discordant pairs was found to be significantly different between two times (p<.0001). The 30-minute interval captured 99% of the rapid cases as defined by either decreased 30-minute or 60-minute retention. Conclusion: Our analysis of GES reports with both 30-minute and 60-minute retention value demonstrated that: 1.) 30-minute interval data diagnosed an additional 27% of patients with rapid emptying as compared to the 60-minute value alone; and 2.) The addition of the 30-minute retention data significantly increases the diagnostic power of GES to identify rapid gastric emptying.

Clinical Utility and Diagnostic Yield of 165 Wireless Capsule Studies at a Tertiary Referral Center

Purpose: To determine the clinical utility and diagnostic yield of wireless motility capsule (WMC) (SmartPill®, Given Imaging, Yoqneam, Israel) in patients with suspected motility disorders of the gastrointestinal tract. Methods: A retrospective chart review of all patients who underwent WMC study from 2009-2012 using a standard protocol at the Cleveland Clinic was performed. Information regarding demographics, symptoms, medication use, past medical and surgical history, indications for WMC, WMC transit times and relevant diagnostic studies were retrieved. Results: A total of 165 subjects were included in the analysis. Mean age was 43 ± 16 years, and 83% were female. Subjects had a median of 4 tests done before undergoing WMC study, and 81% had at least one abnormal test. 78% of subjects had an abnormal WMC, including delayed large bowel transit time (LBTT) (39%), delayed gastric emptying time (GET) (35%) and delayed small bowel transit time (SBTT) (29%). There was no statistical difference in age, gender, symptoms, medication use, past medical or past surgical history between patients with normal vs. abnormal WMC study. In patients who were referred for WMC for evaluation of gastroparesis, small bowel transit time (SBTT) was delayed in 39%, and LBTT was delayed in 28%. Similarly, in patients who underwent WMC for evaluation of constipation, GET was delayed in 27%, and SBTT was delayed in 25%. 25% of patients suspected to have both gastroparesis and constipation had abnormal SBTT. A large number of patients with abnormal gastric emptying scintigraphy (GES) also had abnormal SBTT (36%) and LBTT (41%). Similarly, many patients with abnormal Sitzmarks Study also had delayed GET (50%) and delayed SBTT (15%). Conclusion: Our study indicates that a substantial number of patients with symptoms or motility studies suggestive of gastroparesis or constipation have more generalized gut dysmotility, which can be difficult to evaluate or detect without multiple motility testings. WMC provides a comprehensive regional evaluation of the GI tract transit. Whether the additional information obtained with the WMC influenced the management or outcome in our patient population is unclear and needs to be further investigated.Table

Relation of Scintigraphic Gastric Emptying Delays to Degrees of Gastric Food Retention on Endoscopy in Gastroparesis: Importance of Etiologies, Symptoms, and Medication Use

Relation of Scintigraphic Gastric Emptying Delays to Degrees of Gastric Food Retention on Endoscopy in Gastroparesis: Importance of Etiologies, Symptoms, and Medication Use

Clinical assessment of delayed gastric emptying and diabetic complications using gastric emptying scintigraphy: Involvement of vascular disorder

Delayed gastric emptying, including gastroparesis, is a common complication in diabetes mellitus. The association between delayed gastric emptying and overall diabetic complications remains to be studied in detail. We analysed this association. We performed gastric emptying scintigraphy of (99m) Tc-diethylenetriaminepentaacetic acid in 34 patients with diabetes to measure the gastric emptying half-times (T1/2) of the whole stomach (WS), proximal stomach (PS) and distal stomach (DS). We assessed T1/2, diabetic-related factors and complications. The prevalence of autonomic neuropathy was higher in the group with delayed T1/2 of the WS than in the normal group. Analysis of intima-media thickness (IMT) and ankle brachial pressure index (ABI), which are risk indicators for vascular disorder, showed that IMT of the carotid bulb was greater in the group with delayed T1/2 of the WS than in the normal group (2·41 mm [1·50-2·81] versus 1·40 mm [0·81-2·08], P = 0·015). T1/2 of the WS correlated positively with IMT of the carotid bulb (r = 0·391, P = 0·027) and negatively with ABI (r = -0·389, P = 0·028). These correlations were mainly attributed to PS and were the same in patients without autonomic neuropathy. In seven of nine patients who received scintigraphy again after diabetic treatment, glycosylated haemoglobin (HbA1c) levels decreased and T1/2 of the WS shortened compared with before treatment. Vascular disorder, among other cofactors such as autonomic neuropathy, could be involved in the pathophysiology of delayed gastric emptying. Medium- to long-term glycaemic control was associated with gastric emptying.

Antibodies against gonadotropin-releasing hormone (GnRH) in patients with diabetes mellitus is associated with lower body weight and autonomic neuropathy

BackgroundEsophageal dysmotility and gastroparesis are common secondary complications in patients with diabetes mellitus. Patients with dysmotility express antibodies against gonadotropin-releasing hormone (GnRH) in serum. The aim of the present study was to scrutinize patients with diabetes mellitus with regard to the presence of GnRH antibodies, and to examine associations between antibodies and clinical findings.ResultsThirty-nine consecutive patients with diabetes mellitus were included in the study after clinical examination and examination by esophageal manometry and gastric emptying scintigraphy. Serum was analyzed for the presence of antibodies against GnRH using an ELISA, and values are expressed as relative units (RU). Two age- and gender-matched healthy subjects per each patient served as controls. The prevalence of IgM GnRH antibodies in patients was 33% compared to 14% in controls (p = 0.027), with a higher antibody titer; 1.2 (0.6-5.0) and 0.2 (0.1-0.3) RU, respectively (p = 0.000). The expression of IgG antibodies was 15% in patients and none in controls (p = 0.000). Lower body mass index was associated with the presence of IgM antibodies (OR = 0.835, 95% CI = 0.699–0.998), and autonomic neuropathy with the presence IgG antibodies (OR = 9.000, 95% CI = 1.327–61.025). Esophageal dysmotility (69%) or gastroparesis (18%) were not associated with the presence of IgM antibodies (OR = 0.589, 95% CI = 0.143–2.424 and OR = 3.407, 95% CI = 0.633–18.350, respectively). Neither was esophageal dysmotility associated with IgG antibodies (OR = 2.500, 95% CI = 0.259–24.096).ConclusionsAntibodies against GnRH are more common in patients with diabetes mellitus compared with healthy controls. IgM antibodies are associated with lower body mass index and IgG antibodies are associated with autonomic neuropathy.

Novel and Validated Approaches for Gastric Emptying Scintigraphy in Patients with Suspected Gastroparesis

Controversy exists regarding the relation of upper gastrointestinal symptoms to gastroparesis, which centers on the reportedly weak correlation between symptoms and gastric emptying (GE) measurements. Appropriate management of patients with suspected gastroparesis thus requires the use of validated assessments of GE. GE scintigraphy (GES) using a low-fat EggBeaters (chicken egg white) meal (ConAgra Foods Inc., Omaha, NE, USA) [1] is regarded as the gold standard due to standardized procedures, methods, and well-established normal values. Although this meal has the advantage of good tolerability by the majority of symptomatic patients, there are potential drawbacks: a few patients may not tolerate any solid meal, or the low fat and caloric content may not be able to adequately stress the system, failing to identify impaired gastric motor function in a subset of individuals. Therefore, identification of an alternative, appropriate test meal may be important for clinical and research applications. In this issue, Sachdeva et al. [2] compared GE of the low-fat EggBeaters solid meal (255 kcal containing 2 % fat, 24 % protein, 72 % carbohydrate, and 2 % fiber) to an Ensure Plus (Abbott Laboratories, North Chicago, IL, USA) liquid meal (350 kcal containing 28 % fat, 15 % protein, 57 % carbohydrate, and no fiber) to identify a valid alternative for patients unable to consume the standard low-fat egg-white meal. On separate days, 20 healthy volunteers participated in a well-designed prospective study comparing GES with these two meals; simultaneously, the authors evaluated gastric contractility using a wireless motility capsule (WMC) during both assessments. The objectives were to demonstrate feasibility and to provide hypothesis-generating data (e.g., definition of coefficient of variation [COV; standard deviation/mean] to facilitate the design of future studies). The conclusion that GE of a liquid nutrient meal is similar to that of low-fat egg-white meal (of similar calorie content) is valid, at least in healthy subjects. Nevertheless, as acknowledged by the authors, their results will require replication in a larger cohort, and in subjects with suspected gastroparesis who might differ from a healthy population in terms of having differential GE of solid versus liquid meals. Jones et al. [3] previously reported a significant but weak (r = 0.42, p 0.01) correlation between GE of solids and nutrient-containing liquids among 86 patients with diabetes mellitus. In the study by Sachdeva et al. [2], the correlation between the GE T1/2 of the two meals was similarly weak (r = 0.53) among healthy subjects, suggesting that there are significant intraindividual differences in the emptying of the two meals, and that less than 30 % of the variance is attributable to the same mechanisms for emptying of the two types of meals. It is also necessary to clarify the inter-individual COV with the EggBeaters and the liquid nutrient meal. Diagnostic interpretation of GE T1/2 by GES in an individual patient requires robust definition of the intra-individual COV with the specific meal used. Thus, the estimated COVinter for GE T1/2 was 25 % with the EggBeaters meal and 24 % using a meal of higher fat and calorie content [4] in which the solid phase is radiolabeled. With the latter radiolabeled solid meal, the COVinter for GE at 4 h was 9.6 %, confirming the recommendation by Tougas et al. [1] that the percent retention at 4 h is an endpoint useful for gastroparesis screening. Similarly, others have shown greater sensitivity of detection of abnormal GE with use of M. Camilleri (&) A. Shin Mayo Clinic, Charlton 8-110, 200 First St. S.W., Rochester, MN 55905, USA e-mail: camilleri.michael@mayo.edu

Su1108 Relationship of Gastrointestinal Symptoms and Psychological Distress to Gastric Emptying in Children Undergoing Gastric Emptying Scintigraphy

and the number of servings of fruits, vegetables, caffeinated beverages, and dariy products consumed on a typical day. RESULTS: Out of 26 cases who completed both questionnaires, N=16 showed an improvement of .1 point in GI symptom scores (on a scale = 0-40), with 10 showing no change (N=6) or worse symptoms (N=4). In the group that showed improvement, the following factors improved as well: Anxiety (M= 5.42 in spring; M= 3.11 in summer, p,0.003), parental protective responses (M=14.7 in spring, M=11.9 in summer, p,0.05), vegetable consumption (M=2.71 in spring, M=1.62 in summer, p,0.048), intense physical activity (M=1.69 in spring, M=1.00 in summer, p,0.024) and sleep quality (M= 31.3 in spring, M=36.1 in summer, p,0.009). The degree of change in pain was correlated with the degree of change in fast food (r=.76), caffeine (r=.63), protectiveness (r=-.36), and free time (r=.40). In the group who did not show improvement in pain or pain deteriorated during the summer, a decrease in stress level (M=2.10 in spring, M=1.50 in summer, p,0.024) was observed. Degree of changes in pain were correlated with degree of changes in skipping of breakfast (r=.45), vegetable consumption (r=-.72), and caffeine (r=.46). CONCLUSIONS: This is the first study to identify factors that may explain seasonal variation in FAP. If abdominal pain improves, anxiety, sleep quality, vegetable consumption, parental response to child's pain and physical activity also show improvements during the summer. We do not know from this pilot work if these factors cause or result from the changes in abdominal pain. Longitudinal studies with larger samples are needed. This type of research is important in revealing future targets in the prevention and management of FAP.

Mo2083 Gastric Emptying Scintigraphy in Patients: Effect of Different Curve Fitting Techniques and Duration of Imaging to Estimate T-1/2

Mo2083 Gastric Emptying Scintigraphy in Patients: Effect of Different Curve Fitting Techniques and Duration of Imaging to Estimate T-1/2

Use of a High Caloric Liquid Meal as an Alternative to a Solid Meal for Gastric Emptying Scintigraphy

Gastric emptying scintigraphy (GES) using a solid meal is often recommended for the evaluation of gastroparesis. However, some patients cannot tolerate the standardized egg-white sandwich (EWS) solid meal and an alternative meal is needed. The aim of this study was to compare GES, regional gastric emptying, and gastric contractility using a liquid nutrient meal (LNM; Ensure Plus(®)) to those using EWS. Twenty healthy volunteers underwent GES using EWS and LNM on separate days. Gastric emptying was measured using scintigraphy and with a wireless motility capsule (WMC; SmartPill(®)). The gastric emptying half-time with LNM was similar to that with EWS (1.41 ± 0.11 vs 1.52 ± 0.08 h; P = 0.28) and the two were significantly correlated (r = 0.53; P = 0.017). There were time-related differences in gastric emptying of the LNM compared to EWS: in the first hour, gastric retention of EWS was slightly greater than that of LNM, whereas at 3 and 4 h, gastric retention of EWS was slightly less than that of LNM. Regionally, the percentage retention of the meal in the proximal stomach was greater for EWS than for LNM at 0.5 h. WMC gastric emptying times and gastric contractility for the two meals were not significantly different. Overall gastric emptying of the LNM was similar to that of the EWS meal. The LNM empties without a lag phase and takes slightly longer to empty from the distal stomach, likely due to its higher fat content. These differences are likely due to early accommodation with retention of solids in the proximal stomach and the need for trituration of solids. We conclude that this LNM can serve as an alternative to the conventional solid EWS for GES.

Gastroparesis in Children

Scintigraphic gastric emptying study (GES) is the criterion standard for diagnosis of gastroparesis. Adult studies demonstrated that extending GES to 4 hours increases its ability to diagnose delayed gastric emptying. Most pediatric centers assess GES up to 2 hours postmeal. The aim of the present study was to assess the effect of extending GES from 2 to 4 hours in evaluation of children with suspected gastroparesis. We conducted a chart review of all children who had a 4-hour GES with standard radiolabeled solid meal in 2009-2010. Results of GES at 1, 2, and 4 hours were compared. Patients were diagnosed as having gastroparesis using adult criteria: if gastric retention of meal was >90%, 60%, and 10% at 1, 2 and 4 hours, respectively. A telephone survey assessed GES time at top 20 pediatric gastroenterology centers in the United States. Cost of evaluation of patients diagnosed as having gastroparesis was estimated. Full-time equivalents of nuclear medicine technicians and number of nuclear medicine studies done at Ann & Robert H. Lurie Children's Hospital of Chicago from 2007 to 2010 were examined. A total of 71 patients (32 boys, average age 10.8 years) were studied. Sixty-two percent (n=44) children had abnormal GES; 23% (8/35) of them who had normal values at 2 hours had abnormal GES at 4 hours (P<0.0001). Twenty-eight percent of patients had delayed GES at 1 hour: all persisted to have abnormal GES at 2 and 4 hours. Cost of evaluation of a child for gastroparesis was $9014. Only 5 of the top 20 pediatric gastroenterology centers in the United States conducted 4-hour GES. Transitioning from 2 hours to 4 hours only required scheduling adjustments and did not result in limitation in the number of scheduled patients. Extending GES to 4 hours results in a considerable increase in diagnosis of gastroparesis.

Comparison of criteria to truncate gastric emptying tests

Standardized scintigraphic gastric emptying (GE) protocols to detect gastroparesis (GP) require collecting data for 4 h. This investigation was undertaken to compare seven methods to reduce the duration of the test. This was a retrospective study of GE data collected using a standardized protocol at 0, 1, 2, 3, and 4 h for 602 patients being evaluated for GP. The reference standard was GP defined conventionally as percentage of gastric retention (GR) at 4 h (p4) of greater than 10%. For data up to 2 h the results were derived as follows: (a) confirming as being positive for GP if GR at 2 h was greater than 65%, negative for GP if GR at 2 h was less than 45%, and indeterminate otherwise; (b) by linear extrapolation; and (c) by monoexponential extrapolation. For data beyond 2 h, further evaluations were made and results were derived as follows: (a) confirming as being positive for GP if GR at 2.5 h was greater than 40%; (b) ascertainment of GR at 3 h; (c) by biphasic fit; and (d) by observation of maximum GR for normal patients at time points earlier than 4 h. Thirty percent of all patients had GP. Eighty percent were determinate by Method 1; for these patients sensitivity to detect GP was similar (P=0.11) for Methods 1-3 (69-79%). For data beyond 2 h, sensitivity of the seven methods ranged from 64 to 92%, and the sensitivity of every method was significantly lower than that of the reference standard (P<0.001). Considering that sensitivity to detect GP was significantly reduced for data collection limited to 3 h or less, it is not advisable to truncate GE studies earlier than 4 h.

Measurement of gastric emptying by radiopaque markers in patients with diabetes: correlation with scintigraphy and upper gastrointestinal symptoms

Scintigraphy, the gold standard to measure gastric emptying, is expensive and not widely available. Therefore, we compared emptying of radiopaque markers (ROM) from the stomach, by use of fluoroscopy, with scintigraphy in patients with insulin-treated diabetes. On the same day we measured gastric emptying of 20 ROM using fluoroscopy and scintigraphic emptying of a standard solid meal. The subjects also completed a validated gastrointestinal (GI) symptom questionnaire. We included 115 patients with insulin-treated diabetes (median age 53, range 21-69 years; 59 women). A moderately strong correlation was demonstrated between scintigraphic (% retained at 2 h) and ROM emptying (markers retained at 6 h) (r = 0.47; P < 0.0001). Eighty-three patients had delayed gastric emptying with scintigraphy, whereas only 29 patients had delayed emptying of ROM. Of the 29 patients with delayed emptying of ROM, 28 also had delayed scintigraphic emptying. The sensitivity and specificity of the ROM test was 34% and 97%, respectively. Significant correlations were only noted between scintigraphic gastric emptying and GI symptom severity, with the strongest correlations for fullness/early satiety (r = 0.34; P < 0.001) and nausea/vomiting (r = 0.30; P < 0.001). A gastric emptying test with ROM is a widely available screening method to detect delayed gastric emptying in patients with diabetes, where a positive result seems reliable. However, a normal ROM test does not exclude delayed gastric emptying, and if the clinical suspicion of gastroparesis remains, scintigraphy should be performed. Results from scintigraphy also correlate with GI symptom severity, which ROM test did not.

Radical Resection of the Pyloric Antrum and Its Effect on Gastric Emptying After Sleeve Gastrectomy

The surgical technique of laparoscopic sleeve gastrectomy (LSG) has not been fully standardized yet and there is the unresolved question of what is the optimum size of retained pyloric antrum. The aim of our research was to prove that even after a radical resection of the pyloric antrum the physiological stomach evacuation function can still be preserved. Our study was based on 12 patients, who were randomly divided into two groups. Patients undergoing radical antrum resection (RA group) underwent gastric emptying scintigraphy to determine the evacuation half-time (T1/2) and food retention in the 90th minute of the test (%GE) both before the operation and 3 months afterward. Patients in whom the antrum was preserved (PA group) served as a control group for comparison of postoperative weight loss (in kilogram), decrease in body mass index (BMI), and decline in excess weight (%EWL). The resulting changes were statistically processed. In the RA group, the average time T1/2 declined from 57.5 to 32.25 min (p = 0.016) and average retention %GE dropped from 20.5 to 9.5% (p = 0.073). Differences in the average values of weight, BMI, or %EWL between both groups were of no statistical significance (p > 0.8). In the RA group, an increase in gastric emptying postoperatively was noted. Complications such as failure of stomach evacuation were not observed in the RA group. Our results suggest that even more radical resection of the pyloric antrum performed by LSG is possible without concerns of postoperative disorder of the stomach evacuation function.

Gastric Emptying in Patients With Functional Dyspepsia and Patients With Migrain: Author's Reply

TO THE EDITOR: Thank you for your comments, Dr. Lee.1 Gastric scintigraphy is a noninvasive, simple to perform, and quantitative method. This study2 tried to increase the objectivity and reproducibility by examination and interpretation according to the guidelines.3,4 We also tried to obtain our own data on gastric emptying (GE) times in our hospital, because we thought it was important to collect unique data in an individual institute. As Dr. Lee pointed out,1 functional dyspepsia (FD) and control group of this study showed delayed GE compared to previous studies.5,6 We already mentioned about that in the discussion. This might be because there was relatively large proportions of young female subjects enrolled in the FD and control group to match gender and age with the migraine group. Actually, females and premenopausal status showed more delayed GE than males and postmenopausal status,7,8 and a previous study found that female sex is the independent factor related to delayed GE in the patients with FD.9 Secondly, there was no significant correlation between GE and symptoms in our study as pointed out by Dr Lee.1 A tendency of delayed GE was shown in FD patients complaining postprandial fullness and early satiety. Regarding the association between GE parameters and dyspeptic symptoms in patients with FD, larger studies have shown the association of postprandial fullness and nausea with delayed GE.7-8 Our study had the limitation of a single-center study targeting a small number of patients, because we had selected the age and gender matched groups from the FD population who had undergone GE scintigraphy. However, the migraine and normal control groups were enrolled prospectively to perform gastric scintigraphy during the interictal period. Lastly, the relationship between migraine and GE is still controversial,10 and inaccurate evaluation of gastric symptoms during interictal period was the limitation in previous studies. Therefore, we enrolled the migraine patients without gastric symptoms during interictal period in order to minimize overlaps with FD. As pointed out by Dr. Lee,1 it could be better to perform scintigraphy in the ictal period to find the correlation with nausea and vomiting that occurs in the ictal period, but it should not allowed because of an ethical reason. Gastric symptoms, including nausea and vomiting, found in the ictal period might be caused by the central and peripheral nervous mechanisms. Nausea and vomiting in migraine patients during ictal period may be known to be not related to delayed GE, but other mechanisms.

Wireless Motility Capsule Test in Children with Upper Gastrointestinal Symptoms

To compare scintigraphic gastric emptying and antroduodenal manometry (ADM) studies with the wireless motility capsule test in symptomatic pediatric patients. Patients aged 8-17 years with severe upper gastrointestinal symptoms (ie, nausea, vomiting, retching, abdominal pain) referred for ADM were recruited. A standardized protocol for ADM was used. On a different day, participants were given a standardized meal and then swallowed the wireless motility capsule. A wireless receiver unit worn during the study recorded transmitted data. If not performed previously, a 2-hour scintigraphic gastric emptying study was completed at the time of ADM testing. A total of 22 patients were recruited, of whom 21 had complete scintigraphic gastric emptying study data and 20 had complete ADM data. The wireless motility capsule test had 100% sensitivity and 50% specificity in detecting gastroparesis compared with the 2-hour scintigraphic gastric emptying study. The wireless motility capsule test detected motor abnormalities in 17 patients, compared with 10 detected by ADM. Dichotomous comparison yielded a diagnostic difference between ADM and the wireless motility capsule test (P<.01). Migrating motor complexes were recognized in all patients by both ADM and the wireless motility capsule test. The wireless motility capsule test was well tolerated in all patients, and there were no side effects. In symptomatic pediatric patients, the wireless motility capsule test is highly sensitive compared with scintigraphic gastric emptying studies in detecting gastroparesis, and seems to be more sensitive than ADM in detecting motor abnormalities.

Randomized Controlled Phase Ib Study of Ghrelin Agonist, RM-131, in Type 2 Diabetic Women With Delayed Gastric Emptying

OBJECTIVETo investigate the pharmacokinetics (PK), pharmacodynamics, and safety of single-dose RM-131 in type 2 diabetic patients with gastrointestinal cardinal symptoms (GCSI) and previously documented delayed gastric emptying (DGE).RESEARCH DESIGN AND METHODSIn a randomized crossover study, 10 female patients received RM-131 (100 μg s.c.) or placebo and underwent scintigraphic gastric emptying (GE) and colonic filling at 6 h (CF6) of a solid-liquid meal administered 30 min postdosing. Adverse events, plasma glucose, and hormonal levels were assessed. GCSI daily diary (GCSI-DD) was completed during treatments. PK was assessed in this cohort and healthy volunteers (HVs).RESULTSAt screening, HbA1c was 7.2 ± 0.4% (SEM) and total GCSI-DD score was 1.32 ± 0.21. RM-131 accelerated GE t1/2 of solids (P = 0.011); mean difference (Δ) in solid GE t1/2 was 68.3 min (95% CI 20–117) or 66.1%. There were numerical differences in GE lag time, CF6 solids, and GE t1/2 liquids (all P < 0.14). With a significant (P < 0.014) order effect, further analysis of the first treatment period (n = 5 per group) confirmed significant RM-131 effects on GE t1/2 (solids, P = 0.016; liquids, P = 0.024; CF6, P = 0.013). PK was similar in DGE patients and HVs. There were increases in 120-min blood glucose (P = 0.07) as well as 30–90-min area under the curve (AUC) levels of growth hormone, cortisol, and prolactin (all P < 0.02) with single-dose RM-131. Only light-headedness was reported more on RM-131.CONCLUSIONSRM-131 greatly accelerates the GE of solids in patients with type 2 diabetes and documented DGE. PK is similar in diabetic patients and HVs.

Gastric Emptying in Migraine: A Comparison With Functional Dyspepsia

Background/AimsGastric stasis in migraineurs remains controversial. The aim of this study is to investigate gastric emptying (GE) time, and any associations between GE parameters and dyspeptic symptoms among patients with functional dyspepsia (FD) and migraine without any gastrointestinal symptoms during the interictal period.MethodsWe enrolled 27 migraine patients, 32 FD patients and 12 healthy people as controls, and performed GE scintigraphy as gastric function test. Gastrointestinal symptoms were evaluated in the FD and migraine.ResultsThe age-adjusted mean gastric half-emptying time in FD (125.51 ± 52.55 minutes) patients was longer than in migraineurs (100.82 ± 23.94 minutes, P = 0.035) and controls (95.25 ± 23.29 minutes, P = 0.021). The percentage of gastric retention was higher in FD than in migraine. However, migraineurs did not show an obvious delayed gastric emptying or an increase of gastric retention when compared to the normal controls. The association between each dyspeptic symptom and GE parameters was not significant, but postprandial fullness and early satiety showed a tendency of delayed GE. In migraineurs, GE time did not show significant association with nausea and vomiting during interictal periods.ConclusionsDelayed GE does not appear to be a mechanism that patients with FD and migraine have in common. Migraineurs without dyspepsia during interictal period had normal GE, and further study for association with FD should be investigated.

Small Intestinal Bacterial Overgrowth in Gastroparesis

To determine symptoms of small intestinal bacterial overgrowth (SIBO) in gastroparesis patients. Patients undergoing LBT (lactulose breath test) for evaluation of SIBO were included. LBT was considered positive on the basis of three conventional criteria: (1) hydrogen level increase >20 ppm above baseline by 90 min (H2@90min); (2) dual hydrogen peaks (>10 ppm increase over baseline before second peak >20 ppm (DPHBT); and (3) breath methane increase of >20 ppm above baseline by 90 min. Results of gastric emptying scintigraphy (GES) were recorded. Patients completed the Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index. Of 740 patients who underwent LBT from December 2009 to August 2011, 471 underwent GES, with 201 having delayed GES. Of patients with delayed GES who underwent LBT 87 % were female, 23 % diabetic, 49 % used gastric acid suppressants, 29 % used opiate analgesics, 35 % used pro-motility medications, and 27 % had a history of gastrointestinal surgery. Overall, 79 (39 %) patients with gastroparesis had evidence of SIBO by LBT: 30 (15 %) had positive H2@90min, 53 (26 %) positive DPHBT, and 6 (3 %) positive breath methane test. In gastroparesis patients with positive H2@90min, there was increased severity of bloating (3.80 ± 0.20 vs 3.29 ± 0.12; P = 0.02), early satiety (3.57 ± 0.27 vs 3.05 ± 0.13; P = 0.045), and postprandial fullness (4.20 ± 0.18 vs 3.52 ± 0.12; P < 0.01) compared with negative H2@90min patients. No significant difference in symptom severity was seen between positive and negative DPHBT gastroparesis patients. In our cohort, 39 % of gastroparesis patients tested positive for SIBO by LBT. Positive H2@90min testing by LBT was associated with increased symptoms of bloating and excessive fullness during and after meals.

The breath test system involving a novel tracer, ¹³C-uracil and Wagner-Nelson analysis: comparison with the gastric emptying scintigraphy.

In this pilot study, a new breath test system for gastric emptying study has been proposed. The system involves 13C-uracil as a novel tracer and the Wagner-Nelson method for analyzing breath data. In three healthy volunteers, the new breath system allowed quantification of gastric emptying profiles as accurately as the scintigraphic technique. Further validation studies with a lager sample size are needed.

Severity of Dyspeptic Symptoms Correlates with Delayed and Early Variables of Gastric Emptying

A simplified report of gastric retention values at select times is now recommended for scintigraphic gastric emptying test (GET). The purpose of this study was to assess correlation between severity of gastroparetic symptoms and all variables of GET, compared to select variables in clinical use. This was a prospective study of patients referred for scintigraphic GET. The Gastroparesis Cardinal Symptom Index questionnaire was obtained prior to the scintigraphy. Variables determined were lag time, half emptying time (T1/2), retention at 30 min, 1, 2 and 4 h. Statistical analysis was by Spearman rank correlation and Wilcoxon rank test with a significance set at p ≤ 0.05. Seven hundred seventeen patients had GET from 03/09 to 03/11. Results are from 325 patients who did not take medications known to affect GET were analyzed (64.9 % females, mean age 47 ± 18.9 years, 21.8 % diabetics, 78.2 % non-diabetic, of which 7.6 % were post-surgical, primarily post-fundoplication). Combined gastric retention at 2 and 4 h detected delayed GET in 83.5 % non-diabetics and 76.6 % of diabetics. Rapid GET was present in 11 % of patients at 30 min and 4 % at 1 h. Significant positive correlation was observed between nausea, vomiting, loss of appetite and variables of GET, but not with the half-time of emptying (T1/2). Bloating negatively correlated with retention at 2 h. There was no association between duration of symptoms and GET variables. Gastroparetic symptoms correlate with different retention times of GET, but not with T1/2. However, symptoms poorly distinguish between categories of gastroparesis or status of gastric emptying. Delayed GE is best detected by 2 and 4 h retention times, while 30 min and 1 h retention times detect rapid GE.