HEP-FYN 12-Years Follow-up
Primary Purpose
Peptic Ulcer, Dyspepsia, Reflux
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
13C-Urea breath test for Helicobacter Pylori
Questionaire
Sponsored by
About this trial
This is an interventional prevention trial for Peptic Ulcer
Eligibility Criteria
Inclusion Criteria:
- Individuals participating in 5 year follow-up
Exclusion Criteria:
- Individuals not participating in 5 year follow-up
- Moved outside the Region of Southern Denmark or with an unknown address
- Individuals who died
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Hp-screened group
Control group
Arm Description
Screened for Helicobacter Pylori and eradication therapy (1998-99)
primarily unscreened group
Outcomes
Primary Outcome Measures
Economic Evaluation
The overall endpoint is expenditure in Danish kroner (on ulcer drugs, upper gastrointestinal endoscopy, GP consultations, hospital admissions related to peptic ulcer).
Data on resource consumption of these services and procedures is multiplied with relevant unit prices, from the Danish Medicines Agency and the Danish National Board of Health, to assess a health-cost endpoint.
Secondary Outcome Measures
Frequency of symptoms (dyspepsia, reflux)
Drug consumption
Consumption of ulcer drugs including over the counter drugs
Quality of life
Incidence of esophagus- and gastric cancer
Upper gastrointestinal endoscopy / X-ray examinations of esophagus and gastric ventricle.
Frequency of peptic ulcers incl. complicated ulcers
Full Information
NCT ID
NCT02001727
First Posted
September 16, 2013
Last Updated
November 19, 2014
Sponsor
Odense University Hospital
Collaborators
Region of Southern Denmark, University of Southern Denmark
1. Study Identification
Unique Protocol Identification Number
NCT02001727
Brief Title
HEP-FYN 12-Years Follow-up
Official Title
Long-term Effect of Screening and Eradication of Helicobacter Pylori in the General Population - HEP-FYN 12-years Follow-up
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
February 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
Region of Southern Denmark, University of Southern Denmark
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Aims:
Evaluate the long-term effect of screening and eradication of Helicobacter Pylori on the prevalence of dyspepsia, and, as secondary outcomes, to assess the effect on dyspepsia related health-care consumption and quality of life.
To investigate symptoms of gastroesophageal reflux (GER), dyspepsia and the combination of these conditions and the effect on quality of life, prognosis and dyspepsia-related health care expenditure.
Methods:
In 1998-99 20.000 individuals, age 40-65 years, identified by their civil registration number, were allocated by a computerized randomized procedure to HP-screening group and control group. All participants received a questionnaire at inclusion, 1-year and 5-year and now again at 12 year follow-up assessing the prevalence of dyspepsia and quality of life. In addition we will obtain information from registers on, comorbidity, use of endoscopies and prescription medication. An economic evaluation is done alongside the randomized trial.
The primary unscreened group is invited to HP test (13C-urea breath-test) in order to analyze the effect of HP-screening according to HP-status
Expected results:
The study will provide information on the long-term effect of HP-screening and eradication in a population. The study will provide information about the long-term effect on incidence of peptic ulcer in an aging population that is likely to have an increased consumption of ASA and NSAID. Furthermore the study will generate knowledge about the long-term prognosis of dyspepsia and reflux in the population (dyspepsia and reflux. Preliminary results from the 5-yr follow-up (13) showed that is has a great influence on quality of life and the dyspepsia-related health care consumption, whether the individual has solely reflux, solely dyspepsia or a combination of both symptoms.
Long-term follow-up and further analyses of these findings could have great impact on management and treatment of individuals with symptoms. It is important to focus on groups; in which the symptoms have the greatest influence on quality of life of the individual. This finding has not been displayed in other studies.
Detailed Description
Questionnaire:
Information on abdominal symptoms (GRSR: Gastrointestinal symptom rating scale, rate of symptoms, quality of life (SF-36, EQ-5D-5L), consumption of ulcer drugs including over the counter drugs, hospital admissions, dyspepsia-related sick leave days, consultations and comorbidity). A reminder is sent out 2 weeks after the first contact.
Register data:
OPED (Odense Pharmaca-epidemiological Database): Information on reimbursable ulcer drugs, ASA, NSAID and HP-eradication therapy. The Regional Hospital discharge Register: Information based on International Classification of Diseases (ICD). Information on ulcer-related admissions, out-patient ulcer diagnosis and comorbidity, use of upper gastrointestinal endoscopy.
HP-test unscreened group:
Invitation of the primary unscreened group to HP test (13C-urea breath-test) in order to analyze the effect of HP-screening according to HP-status. Instruments: automated breath 13Co2 analyser- Isotope ratio mass spectrometer.
Almost all persons are infected with HP during childhood. Infection with the bacteria in adulthood is rare. Only few persons spontaneously turn HP-negative. From OPED we will know which individuals who have been prescribed HP-eradication treatment. Thus the participants in the control group, who are HP-positive at 12-yr follow-up, have had the infection the whole period. Provided they have not received HP-eradication treatment, those who are tested HP-negative have been so the whole period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcer, Dyspepsia, Reflux
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hp-screened group
Arm Type
Active Comparator
Arm Description
Screened for Helicobacter Pylori and eradication therapy (1998-99)
Arm Title
Control group
Arm Type
Other
Arm Description
primarily unscreened group
Intervention Type
Other
Intervention Name(s)
13C-Urea breath test for Helicobacter Pylori
Intervention Type
Other
Intervention Name(s)
Questionaire
Primary Outcome Measure Information:
Title
Economic Evaluation
Description
The overall endpoint is expenditure in Danish kroner (on ulcer drugs, upper gastrointestinal endoscopy, GP consultations, hospital admissions related to peptic ulcer).
Data on resource consumption of these services and procedures is multiplied with relevant unit prices, from the Danish Medicines Agency and the Danish National Board of Health, to assess a health-cost endpoint.
Time Frame
twelve years
Secondary Outcome Measure Information:
Title
Frequency of symptoms (dyspepsia, reflux)
Time Frame
twelve years
Title
Drug consumption
Description
Consumption of ulcer drugs including over the counter drugs
Time Frame
Twelve years
Title
Quality of life
Time Frame
twelve years
Title
Incidence of esophagus- and gastric cancer
Time Frame
Twelve years
Title
Upper gastrointestinal endoscopy / X-ray examinations of esophagus and gastric ventricle.
Time Frame
Twelve Years
Title
Frequency of peptic ulcers incl. complicated ulcers
Time Frame
Twelve years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
52 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Individuals participating in 5 year follow-up
Exclusion Criteria:
Individuals not participating in 5 year follow-up
Moved outside the Region of Southern Denmark or with an unknown address
Individuals who died
12. IPD Sharing Statement
Citations:
PubMed Identifier
28606845
Citation
Bomme M, Hansen JM, Wildner-Christensen M, Hallas J, Schaffalitzky de Muckadell OB. Effects of Community Screening for Helicobacter pylori: 13-Year Follow-Up Evaluation of a Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2017 Nov;15(11):1715-1723.e7. doi: 10.1016/j.cgh.2017.06.006. Epub 2017 Jun 9.
Results Reference
derived
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HEP-FYN 12-Years Follow-up
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