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El Ansari W, El-Menyar A, Sathian B, Al-Thani H, Al-Kuwari M, Al-Ansari A. Is Routine Preoperative Esophagogastroduodenoscopy Prior to Bariatric Surgery Mandatory? Systematic Review and Meta-analysis of 10,685 Patients. Obes Surg 2020; 30:3073-3083. [PMID: 32468339 PMCID: PMC7305097 DOI: 10.1007/s11695-020-04672-4] [Citation(s) in RCA: 16] [Impact Index Per Article: 3.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
BACKGROUND This systematic review and meta-analysis searched, retrieved and synthesized the evidence as to whether preoperative esophagogastroduodenoscopy (p-EGD) should be routine before bariatric surgery (BS). METHODS Databases searched for retrospective, prospective, and randomized (RCT) or quasi-RCT studies (01 January 2000-30 April 2019) of outcomes of routine p-EGD before BS. STROBE checklist assessed the quality of the studies. P-EGD findings were categorized: Group 0 (no abnormal findings); Group 1 (abnormal findings that do not necessitate changing the surgical approach or postponing surgery); Group 2 (abnormal findings that change the surgical approach or postpone surgery); and Group 3 (findings that signify absolute contraindications to surgery). We assessed data heterogeneity and publication bias. Random effect model was used. RESULTS Twenty-five eligible studies were included (10,685 patients). Studies were heterogeneous, and there was publication bias. Group 0 comprised 5424 patients (56%, 95% CI: 45-67%); Group 1, 2064 patients (26%, 95% CI: 23-50%); Group 2, 1351 patients (16%, 95% CI: 11-21%); and Group 3 included 31 patients (0.4%, 95% CI: 0-1%). CONCLUSION For 82% of patients, routine p-EGD did not change surgical plan/ postpone surgery. For 16% of patients, p-EGD findings necessitated changing the surgical approach/ postponing surgery, but the proportion of postponements due to medical treatment of H Pylori as opposed to "necessary" substantial change in surgical approach is unclear. For 0.4% patients, p-EGD findings signified absolute contraindication to surgery. These findings invite a revisit to whether p-EGD should be routine before BS, and whether it is judicious to expose many obese patients to an invasive procedure that has potential risk and insufficient evidence of effectiveness. Further justification is required.
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Affiliation(s)
- Walid El Ansari
- Department of Surgery, Hamad Medical Corporation, Doha, Qatar
- College of Medicine, Qatar University, Doha, Qatar
- Schools of Health and Education, University of Skovde, Skövde, Sweden
| | - Ayman El-Menyar
- Department of Surgery, Trauma and Vascular Surgery, Clinical Research, Hamad General Hospital, Doha, Qatar
- Clinical Medicine, Weill Cornell Medical School, Doha, Qatar
| | - Brijesh Sathian
- Department of Surgery, Trauma and Vascular Surgery, Clinical Research, Hamad General Hospital, Doha, Qatar
| | - Hassan Al-Thani
- Department of Surgery, Trauma and Vascular Surgery Section, Hamad Medical Corporation, Doha, Qatar
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Sezgin O, Aydın MK, Özdemir AA, Kanık AE. Standard triple therapy in Helicobacter pylori eradication in Turkey: Systematic evaluation and meta-analysis of 10-year studies. TURKISH JOURNAL OF GASTROENTEROLOGY 2020; 30:420-435. [PMID: 31060997 DOI: 10.5152/tjg.2019.18693] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/17/2022]
Abstract
BACKGROUND/AIMS This study aims at evaluating the mean eradication rate by a systematic compilation of the studies which involved the standard triple therapy (STT) in first-line Helicobacter pylori (Hp) eradication in Turkey over a period of 10 years between 2004 and 2013 using the meta-analysis method. MATERIALS AND METHODS The systematic compilation and meta-analysis were carried out according to the PRISMA standards defined in the Cochrane handbook. The results of full-text studies published in national and international journals in English and Turkish languages on Turkish population in a period of 10 years, from 2004 to 2013, are included in this study. The studies include open-label trials, controlled trials, treatment arms, and case series that included a triple therapy regimen consisting of standard doses of a proton pump inhibitor (PPI; omeprazole 20 mg BID, lansoprazole 30 mg BID, pantoprazole 40 mg BID, esomeprazole 40 mg BID, or rabeprazole 20 mg BID) along with clarithromycin 500 mg BID and amoxicillin 1 g BID for 7-14 days. They were scanned electronically via the search engines Google Scholar, PubMed, and the Turkish Medicine Index using specific keywords. The related keywords used were Turkey, Helicobacter pylori, infection, standard triple treatment, first-line therapy, eradication, omeprazole, lansoprazole, pantoprazole, rabeprazole, esomeprazole, clarithromycin, and amoxicillin. Studies carried out with adults were included in the evaluation. The publication year of the studies and the included number of patients, their age, gender, treatment duration (7, 10, and 14 days), and PPIs used were evaluated by two separate gastroenterologists and biostatisticians. Studies that used at least one reliable method (histology, urea breath test (UBT), or Helicobacter pylori stool antigen (HpSA) test) four weeks after completing the treatment for the control of Hp eradication were included. Only naive patients were accepted, and patients who had previously received eradication treatment were excluded. The effectiveness of the Hp eradication was analyzed using an intention-to-treat (ITT) or per-protocol (PP) analysis. RESULTS The STT regime of 45 studies complying with the inclusion criteria was evaluated. A total of 3715 patients were included in the study. Of the 3010 patients whose gender information was available, 55% were women and 45% were men; the weighted age average given explicitly in the studies was 42.14±0.67. The treatment lasted for 14 days in 42 studies, for 7 days in six studies, and for 10 days in 1 study. The eradication rates evaluated according to the ITT and PP analyses were 60% (95% CI: 56%-63%) and 57% (95% CI: 51%-62%), respectively. The rates for 7 days of treatment were 57% (95% CI: 46%-68%) and 60% (95% CI: 51%-67%) and for 14 days of treatment were 60% (95% CI: 56%-63%) and 56% (95% CI: 50%-62%), respectively. The ITT eradication rate of the only 10-day study was 78% (95% CI: 66%-86%). In the meta-regression analysis, the treatment duration, PPI, age, and gender ratio (women/men) used for the ITT analysis had no effect. The gender ratio and age were not considered in this analysis because they were not clearly stated in studies using the PP analysis. The duration of treatment and the PPI used had no effect. CONCLUSION A systematic meta-analysis of studies conducted during the period 2004-2013 in Turkey revealed that the rate of first-line Hp eradication using STT was unacceptably low, and the duration of treatment and PPI used made no difference.
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Affiliation(s)
- Orhan Sezgin
- Department of Gastroenterology, Mersin University School of Medicine, Mersin, Turkey
| | | | - Asena Ayça Özdemir
- Department of Biostatistics, Mersin University School of Medicine, Mersin, Turkey
| | - Arzu Emine Kanık
- Department of Biostatistics, Health Sciences University School of Medicine, İstanbul, Turkey
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Best LMJ, Takwoingi Y, Siddique S, Selladurai A, Gandhi A, Low B, Yaghoobi M, Gurusamy KS, Cochrane Upper GI and Pancreatic Diseases Group. Non-invasive diagnostic tests for Helicobacter pylori infection. Cochrane Database Syst Rev 2018; 3:CD012080. [PMID: 29543326 PMCID: PMC6513531 DOI: 10.1002/14651858.cd012080.pub2] [Citation(s) in RCA: 90] [Impact Index Per Article: 12.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/30/2023]
Abstract
BACKGROUND Helicobacter pylori (H pylori) infection has been implicated in a number of malignancies and non-malignant conditions including peptic ulcers, non-ulcer dyspepsia, recurrent peptic ulcer bleeding, unexplained iron deficiency anaemia, idiopathic thrombocytopaenia purpura, and colorectal adenomas. The confirmatory diagnosis of H pylori is by endoscopic biopsy, followed by histopathological examination using haemotoxylin and eosin (H & E) stain or special stains such as Giemsa stain and Warthin-Starry stain. Special stains are more accurate than H & E stain. There is significant uncertainty about the diagnostic accuracy of non-invasive tests for diagnosis of H pylori. OBJECTIVES To compare the diagnostic accuracy of urea breath test, serology, and stool antigen test, used alone or in combination, for diagnosis of H pylori infection in symptomatic and asymptomatic people, so that eradication therapy for H pylori can be started. SEARCH METHODS We searched MEDLINE, Embase, the Science Citation Index and the National Institute for Health Research Health Technology Assessment Database on 4 March 2016. We screened references in the included studies to identify additional studies. We also conducted citation searches of relevant studies, most recently on 4 December 2016. We did not restrict studies by language or publication status, or whether data were collected prospectively or retrospectively. SELECTION CRITERIA We included diagnostic accuracy studies that evaluated at least one of the index tests (urea breath test using isotopes such as 13C or 14C, serology and stool antigen test) against the reference standard (histopathological examination using H & E stain, special stains or immunohistochemical stain) in people suspected of having H pylori infection. DATA COLLECTION AND ANALYSIS Two review authors independently screened the references to identify relevant studies and independently extracted data. We assessed the methodological quality of studies using the QUADAS-2 tool. We performed meta-analysis by using the hierarchical summary receiver operating characteristic (HSROC) model to estimate and compare SROC curves. Where appropriate, we used bivariate or univariate logistic regression models to estimate summary sensitivities and specificities. MAIN RESULTS We included 101 studies involving 11,003 participants, of which 5839 participants (53.1%) had H pylori infection. The prevalence of H pylori infection in the studies ranged from 15.2% to 94.7%, with a median prevalence of 53.7% (interquartile range 42.0% to 66.5%). Most of the studies (57%) included participants with dyspepsia and 53 studies excluded participants who recently had proton pump inhibitors or antibiotics.There was at least an unclear risk of bias or unclear applicability concern for each study.Of the 101 studies, 15 compared the accuracy of two index tests and two studies compared the accuracy of three index tests. Thirty-four studies (4242 participants) evaluated serology; 29 studies (2988 participants) evaluated stool antigen test; 34 studies (3139 participants) evaluated urea breath test-13C; 21 studies (1810 participants) evaluated urea breath test-14C; and two studies (127 participants) evaluated urea breath test but did not report the isotope used. The thresholds used to define test positivity and the staining techniques used for histopathological examination (reference standard) varied between studies. Due to sparse data for each threshold reported, it was not possible to identify the best threshold for each test.Using data from 99 studies in an indirect test comparison, there was statistical evidence of a difference in diagnostic accuracy between urea breath test-13C, urea breath test-14C, serology and stool antigen test (P = 0.024). The diagnostic odds ratios for urea breath test-13C, urea breath test-14C, serology, and stool antigen test were 153 (95% confidence interval (CI) 73.7 to 316), 105 (95% CI 74.0 to 150), 47.4 (95% CI 25.5 to 88.1) and 45.1 (95% CI 24.2 to 84.1). The sensitivity (95% CI) estimated at a fixed specificity of 0.90 (median from studies across the four tests), was 0.94 (95% CI 0.89 to 0.97) for urea breath test-13C, 0.92 (95% CI 0.89 to 0.94) for urea breath test-14C, 0.84 (95% CI 0.74 to 0.91) for serology, and 0.83 (95% CI 0.73 to 0.90) for stool antigen test. This implies that on average, given a specificity of 0.90 and prevalence of 53.7% (median specificity and prevalence in the studies), out of 1000 people tested for H pylori infection, there will be 46 false positives (people without H pylori infection who will be diagnosed as having H pylori infection). In this hypothetical cohort, urea breath test-13C, urea breath test-14C, serology, and stool antigen test will give 30 (95% CI 15 to 58), 42 (95% CI 30 to 58), 86 (95% CI 50 to 140), and 89 (95% CI 52 to 146) false negatives respectively (people with H pylori infection for whom the diagnosis of H pylori will be missed).Direct comparisons were based on few head-to-head studies. The ratios of diagnostic odds ratios (DORs) were 0.68 (95% CI 0.12 to 3.70; P = 0.56) for urea breath test-13C versus serology (seven studies), and 0.88 (95% CI 0.14 to 5.56; P = 0.84) for urea breath test-13C versus stool antigen test (seven studies). The 95% CIs of these estimates overlap with those of the ratios of DORs from the indirect comparison. Data were limited or unavailable for meta-analysis of other direct comparisons. AUTHORS' CONCLUSIONS In people without a history of gastrectomy and those who have not recently had antibiotics or proton ,pump inhibitors, urea breath tests had high diagnostic accuracy while serology and stool antigen tests were less accurate for diagnosis of Helicobacter pylori infection.This is based on an indirect test comparison (with potential for bias due to confounding), as evidence from direct comparisons was limited or unavailable. The thresholds used for these tests were highly variable and we were unable to identify specific thresholds that might be useful in clinical practice.We need further comparative studies of high methodological quality to obtain more reliable evidence of relative accuracy between the tests. Such studies should be conducted prospectively in a representative spectrum of participants and clearly reported to ensure low risk of bias. Most importantly, studies should prespecify and clearly report thresholds used, and should avoid inappropriate exclusions.
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Affiliation(s)
- Lawrence MJ Best
- Royal Free Campus, UCL Medical SchoolDepartment of SurgeryRowland Hill StreetLondonUKNW32PF
| | - Yemisi Takwoingi
- University of BirminghamInstitute of Applied Health ResearchEdgbastonBirminghamUKB15 2TT
| | | | | | | | | | - Mohammad Yaghoobi
- McMaster University and McMaster University Health Sciences CentreDivision of Gastroenterology1200 Main Street WestHamiltonONCanada
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Shirin D, Matalon S, Avidan B, Broide E, Shirin H. Real-world Helicobacter pylori diagnosis in patients referred for esophagoduodenoscopy: The gap between guidelines and clinical practice. United European Gastroenterol J 2016; 4:762-769. [PMID: 28408993 DOI: 10.1177/2050640615626052] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/31/2015] [Accepted: 12/13/2015] [Indexed: 12/19/2022] Open
Abstract
BACKGROUND AND AIMS Histopathology is the most accurate test to detect H. pylori when performed correctly with unknown validity in daily practice clinic settings. We aimed to determine the rate of potentially false-negative H. pylori results that might be due to continued use of proton pump inhibitors (PPIs) in routine endoscopy practice. We also aimed to establish whether gastroenterologists recommend routine cessation of PPIs before esophagogastroduodenoscopy (EGD) and whether they regularly document that biopsies for H. pylori testing have been taken while the patients are on PPI treatment. METHODS Detailed information about three known factors (PPIs, antibiotics and prior H. pylori eradication treatment), which may cause histology or rapid urease test (RUT) to be unreliable, had been prospectively collected through interviews using a questionnaire before each test. Gastric biopsies were stained with H&E for histological analysis. RESULTS A total of 409 individuals at three academic gastroenterology institutions were tested 200 times with histology. Fifty-six per cent (68 of 122) of all negative tests fell in the category of continuing PPI use, which had the potential to make the histology and RUT results unreliable. CONCLUSIONS These data demonstrate a clear and important gap between current guidelines and real-world practice with regards to the diagnosis of H. pylori during EGD. A negative histology or RUT should be considered false negative until potential protocol violations are excluded. Documentation of PPI use during the EGD should be an integral part of the EGD report. The current practice of taking biopsies for H. pylori testing in patients under PPIs should be reevaluated.
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Affiliation(s)
- Dor Shirin
- The Kamila Gonczarowski Institute of Gastroenterology, Assaf Harofeh Medical Center, Zerifin, Israel
| | - Shay Matalon
- The Kamila Gonczarowski Institute of Gastroenterology, Assaf Harofeh Medical Center, Zerifin, Israel
| | - Benjamin Avidan
- Gastroenterology Institute, Sheba Medical Center, Ramat Gan, Israel.,Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel
| | - Efrat Broide
- The Kamila Gonczarowski Institute of Gastroenterology, Assaf Harofeh Medical Center, Zerifin, Israel.,Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel
| | - Haim Shirin
- The Kamila Gonczarowski Institute of Gastroenterology, Assaf Harofeh Medical Center, Zerifin, Israel.,Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel
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Allahverdiyev AM, Bagirova M, Caliskan R, Tokman HB, Aliyeva H, Unal G, Oztel ON, Abamor ES, Toptas H, Yuksel P, Kalayci F, Aslan M, Erzin Y, Bal K, Kocazeybek BS. Isolation and diagnosis of Helicobacter pylori by a new method: Microcapillary culture. World J Gastroenterol 2015; 21:2622-2628. [PMID: 25759529 PMCID: PMC4351211 DOI: 10.3748/wjg.v21.i9.2622] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/14/2014] [Revised: 07/26/2014] [Accepted: 11/11/2014] [Indexed: 02/06/2023] Open
Abstract
AIM: To investigate the performance of the microcapillary culture method (MCM) in Helicobacter pylori (H. pylori) isolation and diagnosis.
METHODS: Microcapillary culture (MC), classical culture (CC), rapid urease (CLO) test, and histopathologic examination (HE) were performed with biopsy samples. Homogenized biopsy samples were loaded into capillary tubes and incubated for 48 h at 37 °C without providing a microaerophilic environment. Additionally, three or four loops of the homogenized sample were inoculated in a ready-to-use selective medium (Becton Dickinson, Helicobacter Agar, Modified) specific for the isolation of H. pylori and incubated at 37 °C in a microaerophilic atmosphere provided by CampyGen (Becton Dickinson, GasPack). Bacteria reproducing in microcapillary tubes were evaluated in an inverted microscope and also were evaluated after performing a CC with the content. Results obtained by CC, CLO test, and HE were compared with those of MC. The diagnostic performances of the methods used in this study were evaluated for specificity, sensitivity, positive predictive value (PPV), negative predictive value (NPV), and CI.
RESULTS: H. pylori was found positive by CLO test + HE and/or CC culture in 26 patient antrum and corpus biopsy samples. In 25 (25/26) patient biopsy samples, H. pylori was isolated by MCM, whereas in only 14 (14/26) patient biopsy samples, H. pylori was isolated by CC. CLO test and HE were found positive in 17 (17/26) patient biopsy samples. Comparing the results of the isolation of H. pylori by MCM, CC, CLO test, and HE, the sensitivity of the MCM was found as 96%, the specificity as 80%, the PPV as 83%, the NPV as 95%, and the 95%CI as 0.76 (χ2 = 31.51, P < 0.01) whereas the sensitivity of the CC was found as 54% (χ2 = 19.15, P < 0.01), and the sensitivity of the CLO test and HE were found as 65% (χ2 = 25.26, P < 0.01).
CONCLUSION: This new microcapillary cultivation method for H. pylori has high diagnostic sensitivity compared with CC, HE, and CLO tests.
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Shimoyama T. Stool antigen tests for the management of Helicobacter pylori infection. World J Gastroenterol 2013; 19:8188-8191. [PMID: 24363508 PMCID: PMC3857440 DOI: 10.3748/wjg.v19.i45.8188] [Citation(s) in RCA: 77] [Impact Index Per Article: 6.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/26/2013] [Revised: 10/29/2013] [Accepted: 11/12/2013] [Indexed: 02/06/2023] Open
Abstract
Stool antigen tests (SATs) are noninvasive diagnostic modules for Helicobacter pylori (H. pylori) infection. Two types of SATs exist for the diagnosis of H. pylori infection, one based on enzyme immunoassay (EIA) and another on immunochromatography (ICA). SATs do not require expensive chemical agents or specified equipment; hence, they are less expensive compared with the urea breath test. Both European and Japanese guidelines have shown that EIA-based SATs using monoclonal antibodies are useful for primary diagnosis as well as for the assessment of eradication therapy. ICA-based tests do not require particular equipment and are therefore useful in developing countries. SATs are also useful for the diagnosis of H. pylori infection in children and post gastric surgery patients. SATs performed via EIA can assess H. pylori infection in a large number of subjects, almost as well as serology. Thus, SATs would be useful or detecting current infection in such a survey to identify and eradicate H. pylori infection. The accuracy of SATs is lower when the stool samples are unformed or watery, because H. pylori-specific antigens in the stool samples are diluted. Temperature and the interval between stool sample collection and measurement also affect the results of SATs. The choice of test kit depends on the sensitivity and specificity in each region and the circumstances of each patient.
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Gisbert JP, Calvet X, Bermejo F, Boixeda D, Bory F, Bujanda L, Castro-Fernández M, Dominguez-Muñoz E, Elizalde JI, Forné M, Gené E, Gomollón F, Lanas Á, Martín de Argila C, McNicholl AG, Mearin F, Molina-Infante J, Montoro M, Pajares JM, Pérez-Aisa A, Pérez-Trallero E, Sánchez-Delgado J. [III Spanish Consensus Conference on Helicobacter pylori infection]. GASTROENTEROLOGIA Y HEPATOLOGIA 2013; 36:340-374. [PMID: 23601856 DOI: 10.1016/j.gastrohep.2013.01.011] [Citation(s) in RCA: 40] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 01/25/2013] [Accepted: 01/31/2013] [Indexed: 01/06/2023]
Affiliation(s)
- Javier P Gisbert
- Servicio de Aparato Digestivo, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IP), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, España.
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Holmes KP, Fang JC, Jackson BR. Cost-effectiveness of six strategies for Helicobacter pylori diagnosis and management in uninvestigated dyspepsia assuming a high resource intensity practice pattern. BMC Health Serv Res 2010; 10:344. [PMID: 21176158 PMCID: PMC3022876 DOI: 10.1186/1472-6963-10-344] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/20/2010] [Accepted: 12/21/2010] [Indexed: 12/14/2022] Open
Abstract
BACKGROUND Initial assessment of dyspepsia often includes noninvasive testing for Helicobacter pylori infection. Commercially available tests vary widely in cost and accuracy. Although there is extensive literature on the cost-effectiveness of H. pylori treatment, there is little information comparing the cost-effectiveness of various currently used, noninvasive testing strategies. METHODS A Markov simulation was used to calculate cost per symptom-free year and cost per correct diagnosis. Uncertainty in outcomes was estimated using probabilistic sensitivity analysis. RESULTS Under the baseline assumptions, cost per symptom-free year was $122 for empiric proton pump inhibitor (PPI) trial, and costs for the noninvasive test strategies ranged from $123 (stool antigen) to $129 (IgG/IgA combined serology). Confidence intervals had significant overlap. CONCLUSIONS Under our assumptions for how testing for H. pylori infection is employed in United States medical practice, the available noninvasive tests all have similar cost-effectiveness between one another as well as with empiric PPI trial.
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Abstract
BACKGROUND Studies comparing new monoclonal fecal tests for evaluating cure of Helicobacter pylori infection after treatment are scarce. The objective was to compare the diagnostic accuracy of three monoclonal stool tests: two rapid in-office tools -RAPID Hp StAR and ImmunoCard STAT! HpSA - and an EIA test - Amplified IDEIA Hp StAR. MATERIALS AND METHODS Diagnostic reliability of the three tests was evaluated in 88 patients at least 8 weeks after H. pylori treatment. Readings of immunochromatographic tests were performed by two different observers. Sensitivity, specificity, positive and negative predictive values and 95% confidence intervals were calculated. RESULTS All tests presented similar performance for post-eradication testing. Sensitivity for detecting persistent infection was 100% for both Amplified IDEIA and RAPID Hp StAR and 90% for ImmunoCard STAT! HpSA. Respective specificities were 94.9%, 92.3-93.6% and 94.9%. Negative predictive values were very high (100%, 100% and 98.7% respectively). But positive predictive values were lower, ranging from 62.5 to 71.4%. CONCLUSION All monoclonal fecal tests in this series presented similar performance in the post-treatment setting. A negative test after treatment adequately predicted cure of the infection. However, nearly a third of tests were false positive, showing a poor predictive yield for persistent infection.
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Abstract
PURPOSE OF REVIEW Multiple diagnostic methods and treatment strategies have been developed to detect and treat the Helicobacter pylori infection. Many of them have stood the test of time; others lost their value with the introduction of new test and treatment modalities. This review focuses on the current diagnostic methods and their clinical implications, as well as on established and novel treatment strategies. RECENT FINDINGS The increasing antimicrobial resistance has resulted in a decline of the success rate of recommended eradication regimens. The current guidelines recommend as first-line treatment clarithromycin, amoxicillin or metronidazole, and proton pump inhibitor twice daily, but recent studies have demonstrated an increasing eradication failure with these regimens. Several treatment modifications have been adopted regarding duration and combination of substances. SUMMARY The currently recommended first-line treatments are effective and well tolerated. In areas with high antimicrobial resistance rates, new antibiotic combinations and modifications in the sequence of drug administration are proposed as alternative treatment options to standard triple therapy. Future treatment strategies have to focus on regional antimicrobial resistance adopted treatment selection and the development of new antibiotics.
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Blanco S, Forné M, Lacoma A, Prat C, Cuesta MA, Latorre I, Viver JM, Fernández G, Molinos S, Domínguez J. Comparison of stool antigen immunoassay methods for detecting Helicobacter pylori infection before and after eradication treatment. Diagn Microbiol Infect Dis 2008; 61:150-5. [DOI: 10.1016/j.diagmicrobio.2008.01.003] [Citation(s) in RCA: 16] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/12/2007] [Revised: 12/20/2007] [Accepted: 01/04/2008] [Indexed: 12/26/2022]
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Bhewa Y, Hilmi I, Cheah PL, Navaratnam P, Goh KL. Evaluation of the monoclonal stool antigen test for Helicobacter pylori in an Asian population with dyspepsia. J Dig Dis 2007; 8:207-10. [PMID: 17970878 DOI: 10.1111/j.1751-2980.2007.00307.x] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
OBJECTIVE Although well established in the West, stool antigen tests (SAT) are not widely used in Asia. Data on the accuracy of this test in Asia is sparse and, to date, there have been no studies looking at the more refined monoclonal SAT. The aim of this study is to validate the diagnostic accuracy of a stool antigen test, Hp STAR, for the detection of Helicobacter pylori. METHODS Consecutive new patients with dyspepsia, referred to the endoscopy unit were recruited. At endoscopy, biopsies were taken for rapid urease tests and histology. Stool specimens were collected before any therapy was given and were tested for H. pylori using the monoclonal SAT HpSTAR test. Samples were collected from 90 patients. The stool antigen results were compared with the results of rapid urease tests and histopathology, which were used together as the gold standard test in the diagnosis of H. pylori. RESULTS Of the 90 patients tested, 45 were H. pylori positive and 45 were H. pylori negative. There was one false positive and one false negative test. The sensitivity, specificity, positive predictive value and negative predictive value for the Hp STAR were identical: 97.8% with a 95% confidence interval of 88.2-99.9%. The diagnostic accuracy was 97.8% with a 95% confidence interval of 92.2-99.7%. CONCLUSION The monoclonal stool antigen test, HpSTAR is a highly accurate test for the diagnosis of H. pylori.
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Affiliation(s)
- Yusuf Bhewa
- Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia
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Trevisani L, Cifalà V, Fusetti N, Gilli G, Tombesi P, Torchiaro M, Boccia S, Abbasciano V. Diagnostic accuracy of a rapid fecal test to confirm H pylori eradication after therapy: Prospective comparison with a laboratory stool test. World J Gastroenterol 2007; 13:4484-8. [PMID: 17724805 PMCID: PMC4611582 DOI: 10.3748/wjg.v13.i33.4484] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
AIM: To investigate the clinical performances of rapid stool test (ImmunoCard STAT HpSA, Meridian Diagnostic Inc.) in the evaluation of eradication therapy of H pylori and to compare it with a well-known and validated laboratory stool test (Amplified IDEA Hp StAR, Dako).
METHODS: Stool samples of 122 patients were evaluated after eradication therapy of H pylori. H pylori status was assessed by 13C-urea breath test (UBT). Stool specimens were tested using either the rapid immunoassay kit or the laboratory immunoassay kit.
RESULTS: Forty-three patients were infected and 79 non-infected. Sensitivity and specificity of ImmunoCard STAT and Hp StAR were 58.14% and 76.4%, and 97.47% and 98.73%, respectively (P > 0.05). Overall agreement between the two tests was 92.6% (113 of 122 cases).
CONCLUSION: ImmunoCard STAT seems to have rather low performances, and it cannot be regarded as a reliable tool in the post-treatment setting. Also Hp StAR cannot be recommended to confirm H pylori eradication after treatment.
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Affiliation(s)
- Lucio Trevisani
- Centro di Endoscopia Digestiva, Azienda Ospedaliero-Universitaria Arcispedale S Anna, C so Giovecca 203, Ferrara, Italy.
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Abstract
A growing interest in non-invasive tests for the detection of Helicobacter pylori has been observed recently, reflecting a large number of studies published this year. New tests have been validated, and the old ones have been used in different clinical situations or for different purposes. Stool antigen tests have been extensively evaluated in pre- and post-treatment settings both in adults and children, and the urea breath test has been studied as a predictor of bacterial load, severity of gastric inflammation, and response to eradication treatment. Several studies have also explored the usefulness of some serologic markers as indicators of the gastric mucosa status. With regard to invasive tests, molecular methods are being used more and more, but the breakthrough this year was the direct in vivo observation of H. pylori during endoscopy.
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Gisbert JP, de la Morena F, Abraira V. Accuracy of monoclonal stool antigen test for the diagnosis of H. pylori infection: a systematic review and meta-analysis. Am J Gastroenterol 2006; 101:1921-30. [PMID: 16780557 DOI: 10.1111/j.1572-0241.2006.00668.x] [Citation(s) in RCA: 178] [Impact Index Per Article: 9.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
OBJECTIVE To perform a systematic review and a meta-analysis of accuracy of monoclonal stool antigen test (SAT) for the diagnosis of Helicobacter pylori infection. SELECTION OF STUDIES assessing the accuracy of monoclonal SAT for the diagnosis of H. pylori infection. SEARCH STRATEGY electronic and manual bibliographical searches. DATA EXTRACTION independently done by two reviewers. DATA SYNTHESIS meta-analyses combining the sensitivities, specificities, and likelihood ratios (LRs) of the individual studies. RESULTS Twenty-two studies, including 2,499 patients, evaluated the monoclonal SAT before eradication therapy. Pooled sensitivity, specificity, LR+, and LR- were: 0.94 (95% CI 0.93-0.95), 0.97 (0.96-0.98), 24 (15-41), and 0.07 (0.04-0.12). The accuracy of both monoclonal and polyclonal SAT was evaluated together in 13 pretreatment studies, and higher pooled sensitivity was demonstrated with the monoclonal technique (0.95 vs 0.83). Twelve studies, including 957 patients, assessed the monoclonal SAT to confirm eradication after therapy. Pooled sensitivity, specificity, LR+, and LR- were 0.93 (0.89-0.96), 0.96 (0.94-0.97), 17 (12-23), and 0.1 (0.07-0.15). Both tests were evaluated together in eight post-treatment studies and, again, the monoclonal technique showed higher sensitivity (0.91 vs 0.76). Heterogeneity among studies disappeared when a single outlier study was excluded. Subanalysis depending on the reference method, the study population, or the study quality showed similar results. CONCLUSION Monoclonal SAT is an accurate noninvasive method both for the initial diagnosis of H. pylori infection and for the confirmation of its eradication after treatment. The monoclonal technique has higher sensitivity than the polyclonal one, especially in the post-treatment setting.
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Affiliation(s)
- Javier P Gisbert
- Department of Gastroenterology, "La Princesa" University Hospital, Universidad Autónoma, Madrid, Spain
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Domínguez J, Forné M, Blanco S, Prat C, Galí N, Latorre I, Viver JM, Ausina V. Comparison of a monoclonal with a polyclonal antibody-based enzyme immunoassay stool test in diagnosing Helicobacter pylori infection before and after eradication therapy. Aliment Pharmacol Ther 2006; 23:1735-40. [PMID: 16817917 DOI: 10.1111/j.1365-2036.2006.02936.x] [Citation(s) in RCA: 22] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/17/2022]
Abstract
BACKGROUND Detection of Helicobacter pylori antigen in stool samples has been a subject of controversy. However, it has been included in several clinical guidelines as a recommended non-invasive testing procedure in dyspeptic patients. AIM To compare a monoclonal enzyme immunoassay for detection of H. pylori stool antigen (Amplified IDEIA HpStAR, DakoCytomation) with a polyclonal enzyme immunoassay (HpSA test, Premier Platinum HpSA, Meridian Diagnostics) in diagnosing infection and in determining H. pylori status after eradication treatment. METHODS We evaluated stool samples of 198 patients diagnosed with H. pylori infection and of 41 patients without infection. The results of the monoclonal enzyme immunoassay HpStAR were compared with those of the polyclonal enzyme immunoassay HpSA. RESULTS The sensitivity and specificity of HpStAR were 91.9% and 70.7%, while those of HpSA were 89.4% and 80.5%, respectively. In the 126 patients evaluated 6 weeks after eradication therapy, the overall agreement between urea breath test and HpStAR was 90.5% (P = 0.710) and between urea breath test and HpSA was 76.9% (P = 0.410). CONCLUSIONS HpStAR is a rapid and easy-to-perform test with similar sensitivity to HpSA in the diagnosis of H. pylori infection, although it had lower specificity. In contrast, HpStAR is more accurate after eradication therapy than HpSA.
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Affiliation(s)
- J Domínguez
- Servei de Microbiologia, Hospital Universitari Germans Trias i Pujol, Badalona, Departament de Genètica i Microbiologia, Universitat Autònoma de Barcelona, Barcelona, Spain.
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