Evaluation of Efficiency of Esophageal Capsule Endoscopy in the Screening of Patients With Gastroesophageal Reflux Disease or Dyspepsia as Compared to Upper Endoscopy

Nantes University Hospital (NUH)

Status

Completed

Conditions

Dyspepsia

Gastroesophageal Reflux Disease

Treatments

Device: Esophageal Capsule Endoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT00217347

BRD/05/3-J

Details and patient eligibility

About

The exploration of evocative symptoms of esophageal reflux disease or dyspepsia is based on a relatively invasive endoscopic examination, often badly tolerated, and which, in France, is carried out in 50% of the cases under general anaesthesia. The development of a Capsule Endoscopy, of single use, of esophageal exploration (PILLCAM OESO), could allow a painless exploration of the oesophagus, without infectious risk.The aim of this study is to validate the information provided by the Esophageal Capsule Endoscopy compared to upper endoscopy in the screening of patients with gastroesophageal reflux disease or dyspepsia . For that these patients, after being informed and to have given their signed assent, will initially have an exploration by Esophageal Capsule Endoscopy and then, the very same day or within 3 days maximum, a upper endoscopy'. The information provided by the Esophageal Capsule Endoscopy then by the upper endoscopy will be analyzed by investigators different. This study should make it possible to evaluate the parameters of specificity, sensitivity and predictive values of Esophageal Capsule Endoscopy in this indication.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient age is 18 years or older
Patient Suffers from gastroesophageal reflux disease or dyspepsia, did not undergo previous upper endoscopy, with clinical indication to upper endoscopy,able to tolerate an upper endoscopy without general anesthesia
Patient agrees and signs the Informed Consent Form

Exclusion criteria

Dysphagia
Known Zenker's Diverticulum
Known or suspected intestinal obstruction.
Cardiac pacemakers or other implanted electro medical devices.
Female pregnant patient
Upper Endoscopy for control or recent upper endoscopy
Chronic alcoholism defined by a daily consumption of alcohol over 80 g
Severe hepatopathy
Severe, primitive or secondary gastroparesis
Known cancer
Abnormalities of coagulation
Incapacity to understand and sign a sensible consent of participation to the study