Condition category
Digestive System
Date applied
22/01/2010
Date assigned
18/02/2010
Last edited
18/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jean-Louis Frossard

ORCID ID

Contact details

Division of Gastroenterology
Dpt of internal medicine
Geneva University Hospital
Rue Micheli du Crest
1211 geneva 11
Geneva
1211
Switzerland
+41 (0)22 3729346
jean-louis.frossard@hcuge.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

001

Study information

Scientific title

Age, smoking and weight are main contributors for the development of intestinal metaplasia of the cardia

Acronym

Study hypothesis

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

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.

Study design

Observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Assessment of the respective roles of HP, GERD, age, smoking habit and obesity on the development of IMC

Secondary outcome measures

none

Overall trial start date

01/01/2001

Overall trial end date

31/12/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200 (217 at final recruitment)

Participant 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

Recruitment start date

01/01/2001

Recruitment end date

31/12/2004

Locations

Countries of recruitment

Switzerland

Trial participating centre

Division of Gastroenterology,
Geneva
1211
Switzerland

Sponsor information

Organisation

Geneva University Hospital (Switzerland)

Sponsor details

Rue Micheli du Crest
Geneva
1211
Switzerland
+41 (0)22 3729346
jean-louis.frossard@hcuge.ch

Sponsor type

Hospital/treatment centre

Website

http://www.hcuge.ch

Funders

Funder type

Hospital/treatment centre

Funder name

Geneva University Hospital (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes