Helicobacter pylori Diagnostic Tests Used in Europe: Results of over 34,000 Patients from the European Registry on Helicobacter pylori Management

Natalia García-Morales; Ángeles Pérez-Aísa; Giulia Fiorini; Bojan Tepes; Manuel Castro-Fernández; Alfredo Lucendo; Irina Voynovan; Luis Bujanda; Ana Garre; Luis Rodrigo; Samuel Jesús Martínez Domínguez; Maja Denkovski; Jose M. Huguet Malavés; Laimas Jonaitis; Renate Bumane; Oleg Zaytsev; Pilar Mata Romero; Jesús Barrio; Luis Fernández-Salazar; Aiman Silkanovna Sarsenbaeva; Inmaculada Ortiz Polo; Sergey Alekseenko; Ilaria Maria Saracino; Dino Vaira; Alma Keco-Huerga; Dmitry Bordin; Antonio Gasbarrini; Frode Lerang; Theodore Rokkas; Juozas Kupčinskas; Marcis Leja; Gulustan Babayeva; Ricardo Marcos Pinto; Ante Tonkić; Sinead Smith; Perminder Phull; Gyorgy M. Buzas; Halis Simsek; Doron Boltin; Oleksiy Gridnyev; Marino Venerito; Vladimir Milivojevic; Núria Torà; Anna Cano-Català; Leticia Moreira; Olga P. Nyssen; Francis Mégraud; Colm O’Morain; Javier P. Gisbert; Ignasi Puig; Hp-EuReg Investigators

doi:10.3390/jcm12134363

Helicobacter pylori Diagnostic Tests Used in Europe: Results of over 34,000 Patients from the European Registry on Helicobacter pylori Management

Natalia García-Morales, Ángeles Pérez-Aísa, Giulia Fiorini, Bojan Tepes, Manuel Castro-Fernández, Alfredo Lucendo, Irina Voynovan, Luis Bujanda, Ana Garre, Luis Rodrigo, Samuel Jesús Martínez Domínguez, Maja Denkovski, Jose M. Huguet Malavés, Laimas Jonaitis, Renate Bumane, Oleg Zaytsev, Pilar Mata Romero, Jesús Barrio, Luis Fernández-Salazar, Aiman Silkanovna SarsenbaevaInmaculada Ortiz Polo, Sergey Alekseenko, Ilaria Maria Saracino, Dino Vaira, Alma Keco-Huerga, Dmitry Bordin, Antonio Gasbarrini, Frode Lerang, Theodore Rokkas, Juozas Kupčinskas, Marcis Leja, Gulustan Babayeva, Ricardo Marcos Pinto, Ante Tonkić, Sinead Smith, Perminder Phull, Gyorgy M. Buzas, Halis Simsek, Doron Boltin, Oleksiy Gridnyev, Marino Venerito, Vladimir Milivojevic, Núria Torà, Anna Cano-Català, Leticia Moreira, Olga P. Nyssen^*, Francis Mégraud, Colm O’Morain, Javier P. Gisbert, Ignasi Puig, Hp-EuReg Investigators

^*Corresponding author for this work

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Abstract

Background and aims: Several methods are available to diagnose Helicobacter pylori infection. Our objective was to evaluate the tests used for both the initial diagnosis and the confirmation of eradication after treatment in Europe. Methods: The European Registry on the management of Helicobacter pylori infection is an international, multicentre, prospective, non-interventional registry aiming to evaluate the management of Helicobacter pylori-infected patients in Europe. Countries with at least 100 cases registered from June 2013 to April 2021, and with a validated diagnostic method were analysed. Data were quality reviewed. Results: A total of 34,920 adult patients from 20 countries were included (mean age 51 years; 61% women). To establish the initial diagnosis, invasive tests were performed in 19,801 (71%) patients, non-invasive in 11,369 (41%), and both in 3437 (12%). The most frequent were histology (n = 11,885; 43%), a rapid urease test (n = 10,636; 38%) and an urea breath test (n = 7577; 27%). According to the age, invasive tests were indicated in 11,179 (77%) ≥50 years, and in 8603 (65%) <50 years. Depending on the country, the use of invasive tests ranged from 29–99% in <50 years to 60–99% in ≥50. Most of the tests used to confirm eradication were non-invasive (n = 32,540; 93%), with the urea breath test being the most frequent (n = 32,540; 78%). In 2983 (9%) post-treatment tests, histology (n = 1887; 5%) or a rapid urease test (n = 1223; 4%) were performed. Conclusion: A great heterogeneity was observed for the initial diagnosis and confirmation of the eradication. The reasons for the apparent lack of adherence to the clinical guidelines should be further explored.

Original language	English
Article number	4363
Number of pages	14
Journal	Journal of Clinical Medicine
Volume	12
Issue number	13
Early online date	28 Jun 2023
DOIs	https://doi.org/10.3390/jcm12134363
Publication status	Published - Jul 2023

Bibliographical note

Funding Information:
This study was funded by Richen; however, clinical data were not accessible and the company was not involved in any stage of the Hp-EuReg study (design, data collection, statistical analysis, or manuscript writing). We want to thank Richen for their support. This project was promoted and funded by the European Helicobacter and Microbiota Study Group (EHMSG), the Spanish Association of Gastroenterology (AEG) and the Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd). The Hp-EuReg was co-funded by the European Union programme HORIZON (grant agreement number 101095359) and supported by the UK Research and Innovation (grant agreement number 10058099). The Hp-EuReg was co-funded by the European Union programme EU4Health (grant agreement number 101101252).

Acknowledgments
We want to especially thank Sylva-Astrik Torossian for her assistance in language editing. Natalia García Morales is the first author who is acting as the submission’s guarantor. All authors approved the final version of the manuscript.

Data Availability Statement

All data relevant to the study are included in the article or uploaded as Supplementary Information. The data supporting the conclusions of this study are not publicly available, as their content may compromise the privacy of research participants. However, previous published data on the Hp-EuReg study, or de-identified raw data referring to current study, as well as further information on the methods used to explore the data could be shared, with no particular time constraint. Individual participant data will not be shared.

Keywords

diagnostic tests
gastrointestinal endoscopy
Helicobacter pylori
histology
urea breath test

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García-Morales, N., Pérez-Aísa, Á., Fiorini, G., Tepes, B., Castro-Fernández, M., Lucendo, A., Voynovan, I., Bujanda, L., Garre, A., Rodrigo, L., Martínez Domínguez, S. J., Denkovski, M., Huguet Malavés, J. M., Jonaitis, L., Bumane, R., Zaytsev, O., Mata Romero, P., Barrio, J., Fernández-Salazar, L., ... Hp-EuReg Investigators (2023). Helicobacter pylori Diagnostic Tests Used in Europe: Results of over 34,000 Patients from the European Registry on Helicobacter pylori Management. Journal of Clinical Medicine, 12(13), Article 4363. https://doi.org/10.3390/jcm12134363

García-Morales, N, Pérez-Aísa, Á, Fiorini, G, Tepes, B, Castro-Fernández, M, Lucendo, A, Voynovan, I, Bujanda, L, Garre, A, Rodrigo, L, Martínez Domínguez, SJ, Denkovski, M, Huguet Malavés, JM, Jonaitis, L, Bumane, R, Zaytsev, O, Mata Romero, P, Barrio, J, Fernández-Salazar, L, Sarsenbaeva, AS, Ortiz Polo, I, Alekseenko, S, Saracino, IM, Vaira, D, Keco-Huerga, A, Bordin, D, Gasbarrini, A, Lerang, F, Rokkas, T, Kupčinskas, J, Leja, M, Babayeva, G, Marcos Pinto, R, Tonkić, A, Smith, S, Phull, P, Buzas, GM, Simsek, H, Boltin, D, Gridnyev, O, Venerito, M, Milivojevic, V, Torà, N, Cano-Català, A, Moreira, L, Nyssen, OP, Mégraud, F, O’Morain, C, Gisbert, JP, Puig, I & Hp-EuReg Investigators 2023, 'Helicobacter pylori Diagnostic Tests Used in Europe: Results of over 34,000 Patients from the European Registry on Helicobacter pylori Management', Journal of Clinical Medicine, vol. 12, no. 13, 4363. https://doi.org/10.3390/jcm12134363

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abstract = "Background and aims: Several methods are available to diagnose Helicobacter pylori infection. Our objective was to evaluate the tests used for both the initial diagnosis and the confirmation of eradication after treatment in Europe. Methods: The European Registry on the management of Helicobacter pylori infection is an international, multicentre, prospective, non-interventional registry aiming to evaluate the management of Helicobacter pylori-infected patients in Europe. Countries with at least 100 cases registered from June 2013 to April 2021, and with a validated diagnostic method were analysed. Data were quality reviewed. Results: A total of 34,920 adult patients from 20 countries were included (mean age 51 years; 61% women). To establish the initial diagnosis, invasive tests were performed in 19,801 (71%) patients, non-invasive in 11,369 (41%), and both in 3437 (12%). The most frequent were histology (n = 11,885; 43%), a rapid urease test (n = 10,636; 38%) and an urea breath test (n = 7577; 27%). According to the age, invasive tests were indicated in 11,179 (77%) ≥50 years, and in 8603 (65%) <50 years. Depending on the country, the use of invasive tests ranged from 29–99% in <50 years to 60–99% in ≥50. Most of the tests used to confirm eradication were non-invasive (n = 32,540; 93%), with the urea breath test being the most frequent (n = 32,540; 78%). In 2983 (9%) post-treatment tests, histology (n = 1887; 5%) or a rapid urease test (n = 1223; 4%) were performed. Conclusion: A great heterogeneity was observed for the initial diagnosis and confirmation of the eradication. The reasons for the apparent lack of adherence to the clinical guidelines should be further explored.",

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author = "Natalia Garc{\'i}a-Morales and {\'A}ngeles P{\'e}rez-A{\'i}sa and Giulia Fiorini and Bojan Tepes and Manuel Castro-Fern{\'a}ndez and Alfredo Lucendo and Irina Voynovan and Luis Bujanda and Ana Garre and Luis Rodrigo and {Mart{\'i}nez Dom{\'i}nguez}, {Samuel Jes{\'u}s} and Maja Denkovski and {Huguet Malav{\'e}s}, {Jose M.} and Laimas Jonaitis and Renate Bumane and Oleg Zaytsev and {Mata Romero}, Pilar and Jes{\'u}s Barrio and Luis Fern{\'a}ndez-Salazar and Sarsenbaeva, {Aiman Silkanovna} and {Ortiz Polo}, Inmaculada and Sergey Alekseenko and Saracino, {Ilaria Maria} and Dino Vaira and Alma Keco-Huerga and Dmitry Bordin and Antonio Gasbarrini and Frode Lerang and Theodore Rokkas and Juozas Kup{\v c}inskas and Marcis Leja and Gulustan Babayeva and {Marcos Pinto}, Ricardo and Ante Tonki{\'c} and Sinead Smith and Perminder Phull and Buzas, {Gyorgy M.} and Halis Simsek and Doron Boltin and Oleksiy Gridnyev and Marino Venerito and Vladimir Milivojevic and N{\'u}ria Tor{\`a} and Anna Cano-Catal{\`a} and Leticia Moreira and Nyssen, {Olga P.} and Francis M{\'e}graud and Colm O{\textquoteright}Morain and Gisbert, {Javier P.} and Ignasi Puig and {Hp-EuReg Investigators}",

note = "Funding Information: This study was funded by Richen; however, clinical data were not accessible and the company was not involved in any stage of the Hp-EuReg study (design, data collection, statistical analysis, or manuscript writing). We want to thank Richen for their support. This project was promoted and funded by the European Helicobacter and Microbiota Study Group (EHMSG), the Spanish Association of Gastroenterology (AEG) and the Centro de Investigaci{\'o}n Biom{\'e}dica en Red de Enfermedades Hep{\'a}ticas y Digestivas (CIBERehd). The Hp-EuReg was co-funded by the European Union programme HORIZON (grant agreement number 101095359) and supported by the UK Research and Innovation (grant agreement number 10058099). The Hp-EuReg was co-funded by the European Union programme EU4Health (grant agreement number 101101252). Acknowledgments We want to especially thank Sylva-Astrik Torossian for her assistance in language editing. Natalia Garc{\'i}a Morales is the first author who is acting as the submission{\textquoteright}s guarantor. All authors approved the final version of the manuscript.",

year = "2023",

month = jul,

doi = "10.3390/jcm12134363",

language = "English",

volume = "12",

journal = "Journal of Clinical Medicine",

issn = "2077-0383",

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TY - JOUR

T1 - Helicobacter pylori Diagnostic Tests Used in Europe

T2 - Results of over 34,000 Patients from the European Registry on Helicobacter pylori Management

AU - García-Morales, Natalia

AU - Pérez-Aísa, Ángeles

AU - Fiorini, Giulia

AU - Tepes, Bojan

AU - Castro-Fernández, Manuel

AU - Lucendo, Alfredo

AU - Voynovan, Irina

AU - Bujanda, Luis

AU - Garre, Ana

AU - Rodrigo, Luis

AU - Martínez Domínguez, Samuel Jesús

AU - Denkovski, Maja

AU - Huguet Malavés, Jose M.

AU - Jonaitis, Laimas

AU - Bumane, Renate

AU - Zaytsev, Oleg

AU - Mata Romero, Pilar

AU - Barrio, Jesús

AU - Fernández-Salazar, Luis

AU - Sarsenbaeva, Aiman Silkanovna

AU - Ortiz Polo, Inmaculada

AU - Alekseenko, Sergey

AU - Saracino, Ilaria Maria

AU - Vaira, Dino

AU - Keco-Huerga, Alma

AU - Bordin, Dmitry

AU - Gasbarrini, Antonio

AU - Lerang, Frode

AU - Rokkas, Theodore

AU - Kupčinskas, Juozas

AU - Leja, Marcis

AU - Babayeva, Gulustan

AU - Marcos Pinto, Ricardo

AU - Tonkić, Ante

AU - Smith, Sinead

AU - Phull, Perminder

AU - Buzas, Gyorgy M.

AU - Simsek, Halis

AU - Boltin, Doron

AU - Gridnyev, Oleksiy

AU - Venerito, Marino

AU - Milivojevic, Vladimir

AU - Torà, Núria

AU - Cano-Català, Anna

AU - Moreira, Leticia

AU - Nyssen, Olga P.

AU - Mégraud, Francis

AU - O’Morain, Colm

AU - Gisbert, Javier P.

AU - Puig, Ignasi

AU - Hp-EuReg Investigators

N1 - Funding Information: This study was funded by Richen; however, clinical data were not accessible and the company was not involved in any stage of the Hp-EuReg study (design, data collection, statistical analysis, or manuscript writing). We want to thank Richen for their support. This project was promoted and funded by the European Helicobacter and Microbiota Study Group (EHMSG), the Spanish Association of Gastroenterology (AEG) and the Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd). The Hp-EuReg was co-funded by the European Union programme HORIZON (grant agreement number 101095359) and supported by the UK Research and Innovation (grant agreement number 10058099). The Hp-EuReg was co-funded by the European Union programme EU4Health (grant agreement number 101101252). Acknowledgments We want to especially thank Sylva-Astrik Torossian for her assistance in language editing. Natalia García Morales is the first author who is acting as the submission’s guarantor. All authors approved the final version of the manuscript.

PY - 2023/7

Y1 - 2023/7

N2 - Background and aims: Several methods are available to diagnose Helicobacter pylori infection. Our objective was to evaluate the tests used for both the initial diagnosis and the confirmation of eradication after treatment in Europe. Methods: The European Registry on the management of Helicobacter pylori infection is an international, multicentre, prospective, non-interventional registry aiming to evaluate the management of Helicobacter pylori-infected patients in Europe. Countries with at least 100 cases registered from June 2013 to April 2021, and with a validated diagnostic method were analysed. Data were quality reviewed. Results: A total of 34,920 adult patients from 20 countries were included (mean age 51 years; 61% women). To establish the initial diagnosis, invasive tests were performed in 19,801 (71%) patients, non-invasive in 11,369 (41%), and both in 3437 (12%). The most frequent were histology (n = 11,885; 43%), a rapid urease test (n = 10,636; 38%) and an urea breath test (n = 7577; 27%). According to the age, invasive tests were indicated in 11,179 (77%) ≥50 years, and in 8603 (65%) <50 years. Depending on the country, the use of invasive tests ranged from 29–99% in <50 years to 60–99% in ≥50. Most of the tests used to confirm eradication were non-invasive (n = 32,540; 93%), with the urea breath test being the most frequent (n = 32,540; 78%). In 2983 (9%) post-treatment tests, histology (n = 1887; 5%) or a rapid urease test (n = 1223; 4%) were performed. Conclusion: A great heterogeneity was observed for the initial diagnosis and confirmation of the eradication. The reasons for the apparent lack of adherence to the clinical guidelines should be further explored.

AB - Background and aims: Several methods are available to diagnose Helicobacter pylori infection. Our objective was to evaluate the tests used for both the initial diagnosis and the confirmation of eradication after treatment in Europe. Methods: The European Registry on the management of Helicobacter pylori infection is an international, multicentre, prospective, non-interventional registry aiming to evaluate the management of Helicobacter pylori-infected patients in Europe. Countries with at least 100 cases registered from June 2013 to April 2021, and with a validated diagnostic method were analysed. Data were quality reviewed. Results: A total of 34,920 adult patients from 20 countries were included (mean age 51 years; 61% women). To establish the initial diagnosis, invasive tests were performed in 19,801 (71%) patients, non-invasive in 11,369 (41%), and both in 3437 (12%). The most frequent were histology (n = 11,885; 43%), a rapid urease test (n = 10,636; 38%) and an urea breath test (n = 7577; 27%). According to the age, invasive tests were indicated in 11,179 (77%) ≥50 years, and in 8603 (65%) <50 years. Depending on the country, the use of invasive tests ranged from 29–99% in <50 years to 60–99% in ≥50. Most of the tests used to confirm eradication were non-invasive (n = 32,540; 93%), with the urea breath test being the most frequent (n = 32,540; 78%). In 2983 (9%) post-treatment tests, histology (n = 1887; 5%) or a rapid urease test (n = 1223; 4%) were performed. Conclusion: A great heterogeneity was observed for the initial diagnosis and confirmation of the eradication. The reasons for the apparent lack of adherence to the clinical guidelines should be further explored.

KW - diagnostic tests

KW - gastrointestinal endoscopy

KW - Helicobacter pylori

KW - histology

KW - urea breath test

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U2 - 10.3390/jcm12134363

DO - 10.3390/jcm12134363

M3 - Article

AN - SCOPUS:85165136606

SN - 2077-0383

VL - 12

JO - Journal of Clinical Medicine

JF - Journal of Clinical Medicine

IS - 13

M1 - 4363

ER -

Helicobacter pylori Diagnostic Tests Used in Europe: Results of over 34,000 Patients from the European Registry on Helicobacter pylori Management

Abstract

Bibliographical note

Data Availability Statement

Keywords

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