Dataset Information

Comprehensive assessment of gastric emptying with a stable isotope breath test.

ABSTRACT: The [(13)C]-Spirulina platensis gastric emptying breath test (GEBT) with five samples is accurate relative to scintigraphy. This study was primarily designed to further validate this GEBT using a slightly different process for incorporating [(13)C] in Spirulina and to evaluate the utility of additional samples for assessing early gastric emptying.After a 223 kcal, test meal labeled with (99m) Tc and [(13)C]-S. platensis, scintigraphic images, and five breath samples (45, 90, 120, 180, and 240 min, GEBT5) were collected in 14 controls (Part A). In Part B, nine breath samples were collected at 15, 30, 45, 60, 90, 120, 150, 180, and 240 min (GEBT9) in 30 subjects (15 controls, 15 dyspepsia). Using correlation between [(13)C] breath excretion and scintigraphic emptying, lag time (t(10), time for 10% emptying), emptying at 30 min (GE(30)), and half time (t(50)) were estimated for GEBT5 (Parts A and B) and GEBT9 (Part B).Half time values for scintigraphy, GEBT5, and GEBT9 were highly concordant. t(10) by GEBT9 (90%CI, 6-15 min) was more strongly correlated [CCC 0.80 (95% CI, 0.63-0.90)] with scintigraphy (90% CI, 5-12 min), than GEBT5 [10-19 min, CCC 0.73 (95% CI, 0.54-0.85)]. The correlation between estimated values (GEBT9) and linearly interpolated values (GEBT5) was closer at 60 [CCC 0.95 (95% CI, 0.91-0.97)] than 30 min [CCC 0.81 (95% CI, 0.71-0.89)].The [(13) C]-S. platensis GEBT can accurately measure GE. While 5- and 9-samples are equally accurate for measuring t(50), GEBT9 provides a more comprehensive assessment of early GE (t(10) and GE(30)).

SUBMITTER: Bharucha AE

PROVIDER: S-EPMC3843948 | biostudies-literature | 2013 Jan

REPOSITORIES: biostudies-literature

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Comprehensive assessment of gastric emptying with a stable isotope breath test.

Bharucha A E AE Camilleri M M Veil E E Burton D D Zinsmeister A R AR

Neurogastroenterology and motility 20121206 1

<h4>Background</h4>The [(13)C]-Spirulina platensis gastric emptying breath test (GEBT) with five samples is accurate relative to scintigraphy. This study was primarily designed to further validate this GEBT using a slightly different process for incorporating [(13)C] in Spirulina and to evaluate the utility of additional samples for assessing early gastric emptying.<h4>Methods</h4>After a 223 kcal, test meal labeled with (99m) Tc and [(13)C]-S. platensis, scintigraphic images, and five breath sa ...[more]

PMID: 23216872

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Project description:BackgroundUpper digestive endoscopy with biopsy and histopathological evaluation of the biopsy material is the standard method for diagnosing gastric cancer (GC). However, this procedure may not be widely available for screening in the developing world, whereas in developed countries endoscopy is frequently used without major clinical gain. There is a high demand for a simple and non-invasive test for selecting the individuals at increased risk that should undergo the endoscopic examination. Here, we studied the feasibility of a nanomaterial-based breath test for identifying GC among patients with gastric complaints.MethodsAlveolar exhaled breath samples from 130 patients with gastric complaints (37 GC/32 ulcers / 61 less severe conditions) that underwent endoscopy/biopsy were analyzed using nanomaterial-based sensors. Predictive models were built employing discriminant factor analysis (DFA) pattern recognition, and their stability against possible confounding factors (alcohol/tobacco consumption; Helicobacter pylori) was tested. Classification success was determined (i) using leave-one-out cross-validation and (ii) by randomly blinding 25% of the samples as a validation set. Complementary chemical analysis of the breath samples was performed using gas chromatography coupled with mass spectrometry.ResultsThree DFA models were developed that achieved excellent discrimination between the subpopulations: (i) GC vs benign gastric conditions, among all the patients (89% sensitivity; 90% specificity); (ii) early stage GC (I and II) vs late stage (III and IV), among GC patients (89% sensitivity; 94% specificity); and (iii) ulcer vs less severe, among benign conditions (84% sensitivity; 87% specificity). The models were insensitive against the tested confounding factors. Chemical analysis found that five volatile organic compounds (2-propenenitrile, 2-butoxy-ethanol, furfural, 6-methyl-5-hepten-2-one and isoprene) were significantly elevated in patients with GC and/or peptic ulcer, as compared with less severe gastric conditions. The concentrations both in the room air and in the breath samples were in the single p.p.b.v range, except in the case of isoprene.ConclusionThe preliminary results of this pilot study could open a new and promising avenue to diagnose GC and distinguish it from other gastric diseases. It should be noted that the applied methods are complementary and the potential marker compounds identified by gas-chromatography/mass spectrometry are not necessarily responsible for the differences in the sensor responses. Although this pilot study does not allow drawing far-reaching conclusions, the encouraging preliminary results presented here have initiated a large multicentre clinical trial to confirm the observed patterns for GC and benign gastric conditions.

Project description:ImportanceEarly esophagogastric cancer (OGC) stage presents with nonspecific symptoms.ObjectiveThe aim of this study was to determine the accuracy of a breath test for the diagnosis of OGC in a multicenter validation study.Design, setting, and participantsPatient recruitment for this diagnostic validation study was conducted at 3 London hospital sites, with breath samples returned to a central laboratory for selected ion flow tube mass spectrometry (SIFT-MS) analysis. Based on a 1:1 cancer:control ratio, and maintaining a sensitivity and specificity of 80%, the sample size required was 325 patients. All patients with cancer were on a curative treatment pathway, and patients were recruited consecutively. Among the 335 patients included; 172 were in the control group and 163 had OGC.InterventionsBreath samples were collected using secure 500-mL steel breath bags and analyzed by SIFT-MS. Quality assurance measures included sampling room air, training all researchers in breath sampling, regular instrument calibration, and unambiguous volatile organic compounds (VOCs) identification by gas chromatography mass spectrometry.Main outcomes and measuresThe risk of cancer was identified based on a previously generated 5-VOCs model and compared with histopathology-proven diagnosis.ResultsPatients in the OGC group were older (median [IQR] age 68 [60-75] vs 55 [41-69] years) and had a greater proportion of men (134 [82.2%]) vs women (81 [47.4%]) compared with the control group. Of the 163 patients with OGC, 123 (69%) had tumor stage T3/4, and 106 (65%) had nodal metastasis on clinical staging. The predictive probabilities generated by this 5-VOCs diagnostic model were used to generate a receiver operator characteristic curve, with good diagnostic accuracy, area under the curve of 0.85. This translated to a sensitivity of 80% and specificity of 81% for the diagnosis of OGC.Conclusions and relevanceThis study shows the potential of breath analysis in noninvasive diagnosis of OGC in the clinical setting. The next step is to establish the diagnostic accuracy of the test among the intended population in primary care where the test will be applied.

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Dataset Information

Comprehensive assessment of gastric emptying with a stable isotope breath test.

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Comprehensive assessment of gastric emptying with a stable isotope breath test.

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