RecruitingNCT02328131

European Registry on the Management of Helicobacter Pylori Infection


Sponsor

Javier P. Gisbert

Enrollment

10,000 participants

Start Date

Jun 1, 2013

Study Type

OBSERVATIONAL

Summary

The great diversity of regimens and treatment lines, the different efficacy of these, mostly due to the increase in bacterial antibiotic resistance and regional differences, requires a continuous critical analysis of clinical practice, evaluating systematically the efficacy and safety of the different regimens and the cost-effectiveness of the different diagnostic-therapeutic strategies. This will help in the design of an efficient and optimized treatment that will reduce number of re-treatments, diagnostic tests and the appearance of associated pathologies such as peptic ulcers, gastrointestinal bleeding and, probably, gastric cancers. Therefore, the evaluation of real clinical practice using non-interventionist registries will help to improve the design and organization of European Consensus on the management of H. pylori infection, which is the best way to establish healthcare efficiency. Primary aim To obtain a database registering systematically over a year a large and representative sample of routine clinical practice of European gastroenterologists in order to produce descriptive studies of the management of H. pylori infection. Secondary aims 1. To evaluate H. pylori infection consensus and clinical guidelines implementation in different countries. 2. To perform studies focused on epidemiology, efficacy and safety of the commonly used treatments to eradicate H. pylori. 3. To evaluate accessibility to healthcare technologies and drugs used in the management of H. pylori infection. 4. To allow the development of partial and specific analysis by the participating researchers after approval by the Registry's Scientific Committee Methodology Non-interventionist prospective multicentre international registry promoted by the European Helicobacter Study Group. A renowned gastroenterologist from each country was selected as Local Coordinator (30 countries). They will in turn select up to ten gastroenterologists per country that will register the routine clinical practice consultations they receive over 10 years in an electronic Case Report Form (e-CRF). Variables retrieved will include clinical, diagnostic, treatment, eradication confirmation and outcome data. The database will allow researchers to perform specific subanalysis after approval by the Scientific Committee of the study.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • Infected adult patients by Helicobacter pylori

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Locations(30)

Medical University Wien

Vienna, Austria

CHU de Charleroi, Charleroi

Charleroi, Belgium

Medical University of Sofia

Sofia, Bulgaria

University Hospital Merkur

Zagreb, Croatia

Charles University Faculty of Medicine

Prague, Czechia

Køge University Hospital

Køge, Denmark

University of Tartu

Tartu, Estonia

Herttoniemi Hospital, Helsinki

Helsinki, Finland

Hôpital Pellegrin

Bordeaux, France

Medizin Uni Magdeburg

Magdeburg, Germany

Gastroenterology Clinic, Henry Dunant Hospital

Athens, Greece

Ferencváros Health Centre, Gaastroenterology

Budapest, Hungary

Adelaide Meath Hospital, Dublin

Dublin, Ireland

Studio Gasbarrini

Roma, Italy

Digestive Diseases Centre GASTRO

Riga, Latvia

Lithuanian university of Health Sciences Hospital

Kaunas, Lithuania

Ikazia Ziekenhuis/ Erasmus Medisch Centrum

Rotterdam, Netherlands

Central Hospital of Ostfold

Fredrikstad, Norway

Departament of Gastroenterology, Medical Centre for Postgraduate Education

Warsaw, Poland

Porto

Porto, Portugal

Timisoara

Timișoara, Romania

Central Scientific Research Institute of Gastroenterology

Moscow, Russia

Clinical Center of Serbia

Belgrade, Serbia

DC Rogaska

Rogaška Slatina, Slovenia

Hospital de La Princesa, Madrid

Madrid, Spain

Uppsala University Hospital.

Uppsala, Sweden

University Hospital Basel

Basel, Switzerland

Dokuz Eylul University School of Medicine

Izmir, Turkey (Türkiye)

National Medical University

Kiev, Ukraine

Leeds General Infirmiry Hospital

Leeds, United Kingdom

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NCT02328131