Ignite Creation Date:
2024-05-06 @ 3:36 AM
Last Modification Date:
2024-10-26 @ 11:36 AM
Study NCT ID:
NCT02328131
Status:
RECRUITING
Last Update Posted:
2023-03-01
First Post:
2014-12-19
Brief Title:
European Registry on the Management of Helicobacter Pylori Infection
Sponsor:
Javier P Gisbert
Organization:
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Study Overview
Official Title:
European Registry on the Management of Helicobacter Pylori Infection
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Registrys 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
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 Registrys 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
Detailed Description:
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 WHOs 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
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 Registrys Scientific Committee
METHODS
International multicenter prospective non-interventionist registry promoted by the European Helicobacter Study Group
Scientific Committee
Javier P Gisbert President
Francis Megraud
Colm OMorain
Adrian G McNicholl
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
CountryCentreInvestigator
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 yesno 90 Adverse Events
Type of event intensity duration and relation with treatment
Treatment withdrawal due to adverse events Efficacy
Eradication yesno test used and date
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 WHOs 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
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 Registrys Scientific Committee
METHODS
International multicenter prospective non-interventionist registry promoted by the European Helicobacter Study Group
Scientific Committee
Javier P Gisbert President
Francis Megraud
Colm OMorain
Adrian G McNicholl
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
CountryCentreInvestigator
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 yesno 90 Adverse Events
Type of event intensity duration and relation with treatment
Treatment withdrawal due to adverse events Efficacy
Eradication yesno test used and date
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None