Abstract
Introduction: H. pylori selectively infects the human stomach mucosa, being the most
prevalent chronic infection in the world. Its prevalence correlates with socioeconomic
factors and it is higher in older individuals. H. pylori presence causes chronic
gastritis in 100% of infected patients and is the major cause of relevant diseases such
as atrophic gastritis, peptic ulcer disease and gastric cancer; it is for this reason
that from a public health standpoint it is considered a high impact pathogen, responsible
of a significant morbidity and mortality. Nowadays there are Consensus and Clinical
Guidelines regarding the infection management at a European level and in most of the
states, but no data have shown the level of implementation of these recommendations. The
high costs that this infection carries both socially and to the health system require the
continuous and systematic assessment of the diagnostic and treatment strategies, as well
as the accessibility to diagnostic methods and most efficient drugs.
Aim: To register the treatment, diagnosis and management strategies of H. pylori infected
adult patients in the Digestive Services outpatient clinics throughout Europe.
Methods: 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.
INTRODUCTION
H. pylori presence causes chronic gastritis in 100% of infected patients and is the major
cause of relevant diseases such as atrophic gastritis, peptic ulcer disease and gastric
cancer. H. pylori eradication prevents peptic ulcer recurrence and its complications, and
decreases the incidence of gastric cancer. H. pylori eradication in patients with peptic
ulcer or even functional or non-investigated dyspepsia is a cost-effective strategy.
The most common clinical manifestation of H. pylori infection is dyspepsia, a major
health problem, whose prevalence reaches more than 10% among adult populations with its
attendant burden of morbidity and health system costs in diagnosis and treatment.
Approximately 20% to 30% of people in the community each year report chronic or recurrent
dyspeptic symptoms, and consultations for dyspepsia account for up to 40% of referrals
among gastroenterology outpatients, the "test-and-treat" strategy being the most
cost-effective. Moreover, H. pylori is the major cause of peptic ulcer disease, causing
over 90% of duodenal and 70% of gastric ulcers. Considerable evidence supports that the
nature of the chronic inflammatory process driven by H. pylori is of critical importance
in gastric carcinogenesis (adenocarcinoma and mucosa-associated lymphoid tissue -MALT-
lymphoma). It is for that reason that the WHO's International Agency for Research on
Cancer classified H. pylori as a group 1 (definite) carcinogen.
Scientific evidence demonstrates that diagnosis and eradication of H. pylori is the most
cost-effective strategy in the management of dyspepsia, peptic ulcer and gastric cancer
prevention. The treatment regimens are very diverse and have changed overtime.
Monotherapies and treatments with two drugs did not achieve acceptable eradication rates.
The commonly recommended regimen in most Consensus Conferences is the standard triple
regimen, combining two antibiotics (clarithromycin with amoxicillin or metronidazole) and
a proton pump inhibitor (PPI) for 7 to 14 days. Another recommended alternative is
bismuth-containing quadruple therapy (PPI, tetracycline, metronidazole and bismuth
salts). In the last years, results with new and efficient rescue regimens including
levofloxacin have been published. Lately, new treatments have been proposed, including
non-bismuth quadruple regimens, with two main variants: the "sequential" treatment (an
induction phase with PPI and amoxicillin and a second phase with PPI, clarithromycin and
metronidazole) and the "concomitant" treatment (same four drugs taken altogether).
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.
AIMS
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
To evaluate H. pylori infection consensus and clinical guidelines implementation in
different countries.
To perform studies focused on epidemiology, efficacy and safety of the commonly used
treatments to eradicate H. pylori.
To evaluate accessibility to healthcare technologies and drugs used in the
management of H. pylori infection.
To allow the development of partial and specific analysis by the participating
researchers after approval by the Registry's Scientific Committee.
METHODS
International multicenter prospective non-interventionist registry promoted by the
European Helicobacter Study Group.
Scientific Committee
Local Coordinators
A list of European Countries has been selected. Included countries were those having at
least ten clinical research publications in PubMed regarding H. pylori infection.
In each country a Local Coordinator was selected based on its clinical and research
activity (Table I).
The Local Coordinators will constitute the monitoring and drafting committee of the
registry.
The Local Coordinators will be in charge of selecting up to 10 recruiting investigators
in each country and will be in charge of the follow up and quality of the recruiting;
they will be the link between promoters and recruiting investigators.
Recruiter Investigators
The Recruiting Investigators must be gastroenterologists attending an adult population
with a gastroenterology outpatient clinic that assists H. pylori infected patients.
Before acceptance the outpatient clinic must attend, in a clinical routine basis,
patients in which H. pylori diagnosis or treatment is indicated. Eradication confirmation
tests have to be performed routinely. They will register the study variables of their own
routine clinical practice in an e-CRF.
Study Variables
Anonymised Patient Identifiers
Country/Centre/Investigator
Autonumeric Patient identifier number
Gender
Date of Birth
Ethnic Background History and Comorbidity
Drug allergies
Relevant comorbidities
Current concomitant medication Data on Infection
Indication for diagnosis and treatment
Upper Gastrointestinal tract symptoms
Diagnostic Test for current treatment
Number and type of previous eradication attempts Prescribed Treatment
Drugs
Dosage and intakes per day
Length of treatment Compliance
Adherence to treatment (yes/no >90%) Adverse Events
Type of event, intensity, duration and relation with treatment
Treatment withdrawal due to adverse events. Efficacy
Eradication (yes/no), test used, and date