跳至主要内容
临床试验/NCT02328131
NCT02328131招募中不适用

European Registry on the Management of Helicobacter Pylori Infection

Javier P. Gisbert30 个研究点 分布在 30 个国家目标入组 10,000 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10,000
试验地点
30
主要终点
Prescribed treatment for H. pylori

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Infected adult patients by Helicobacter pylori

排除标准

  • 未提供

结局指标

主要结局

Prescribed treatment for H. pylori

时间窗: 1 year

* Drugs * Dosage and intakes * Length of treatment

次要结局

  • Anonymised patient identifiers(1 year)
  • Adverse Events(1 year)
  • Efficacy of treatment(1 year)

研究者

发起方
Javier P. Gisbert
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Javier P. Gisbert

Javier P. Gisbert MD

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

研究点 (30)

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