Specific contributors for the development of intestinal metaplasia of the cardia

ISRCTN	ISRCTN15324190
DOI	https://doi.org/10.1186/ISRCTN15324190
Protocol serial number	001
Sponsor	Geneva University Hospital (Switzerland)
Funder	Geneva University Hospital (Switzerland)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Jean-Louis Frossard
Scientific

Division of Gastroenterology
Dpt of internal medicine
Geneva University Hospital
Rue Micheli du Crest, 1211 geneva 11
Geneva
1211
Switzerland

Phone	+41 (0)22 3729346
Email	jean-louis.frossard@hcuge.ch

Primary study design	Observational
Study design	Observational cohort study
Secondary study design	Cohort study
Scientific title	Age, smoking and weight are main contributors for the development of intestinal metaplasia of the cardia
Study objectives	The aim of this study was to assess the respective roles of Helicobacter pylori (HP), gastroesophageal reflux, age, smoking habit and obesity on the development of intestinal metaplasia of the cardia (IMC)
Ethics approval(s)	In 2003, at the start of this study no Ethical commission existed. The study design was approved by the head of University Hospital Geneva and University Hospital Lausanne, where the patients were recruited.
Health condition(s) or problem(s) studied	Intestinal metaplasia of the cardia (IMC)
Intervention	217 patients were studied. The appointment letter was sent to the patient with the written information leaflet usually within one week before endoscopy. Patient consent to participate was obtained only upon his/her arrival for the endoscopic procedure. Therefore, all patients signed an informed consent form upon their arrival. Gastroesophageal Reflux Disease (GERD), smoking habit, body mass index (BMI) and age were recorded. Biopsies were histologically evaluated for specialised intestinal metaplasia.
Intervention type	Other
Primary outcome measure(s)	Assessment of the respective roles of HP, GERD, age, smoking habit and obesity on the development of IMC
Key secondary outcome measure(s)	none
Completion date	31/12/2004

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	200
Key inclusion criteria	1. All patients scheduled for an elective digestive endoscopy (upper gastrointestinal endoscopy) over a 3 year period allowing us to include at least 200 patients. 2. Living in Switzerland and can understand French 3. Outpatients only 4. Written informed consent
Key exclusion criteria	1. Age < 18 years 2. Pregnancy 3. Patients unable to give their own consent 4. Patients that had already undergone prior endoscopy 5. Previous history of upper-digestive surgery 6. Severe bleeding diathesis (platelet count <50,000/mm3 7. Prothrombin rate <50%) 8. Psychiatric diseases 9. Allergy to lidocaine
Date of first enrolment	01/01/2001
Date of final enrolment	31/12/2004

Division of Gastroenterology,

Geneva
1211
Switzerland

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan