The objective of this study is to compare TNE with conventional upper GI endoscopy in detecting esophageal mucosal abnormalities, effectiviness of barrier for microorganisme and patients experience with both techniques.
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
What is the diagnostic value of TNE as compared with conventional upper GI
endoscopy in detecting esophageal mucosal abnormalities
Secondary outcome
Is there an effective barier for microorganism using the TNE system?
How do patients experience TNE compared with upper GI endoscopy?
Background summary
Adenocarcinoma is found in 60% of patients with esophageal cancer. An important
risk factor for esophageal adenocarcinoma is Barrett*s esophagus (BE).
BE is a metaplastic change of the lining of the esophagus with replacement of
the normal squamous epithelium by specialized intestinal epithelium. Most of
the patients ( 80%) doesen't have any symptoms of reflux.
It is presently unclear what the actual prevalence of BE is in the general
population. When this is known, it is possible to assertain, if and to which
persons the advice must be given to undergo screening for BE.
One of the disadvantages of standard upper gastrointestinal (GI) endoscopy is
that patients often experience this investigation as burdensome. This could
reduce the compliance of patients to undergo standard upper GI endoscopy for
screening purposes. Therefore, there has been a search for effective
alternatives of standard upper GI endoscopy for this indication.
Therefore e new methode has developped: ultrathin endoscopy has the advantage
over standard endoscopy that the diameter of the endoscope is substantially
thinner(5.3 mm) which makes the technique more tolerable to patients.
Besides, this endoscope has a sterile, disposable Endo-Sheath system. Therefore
high-level disinfection** of the endoscope isn't needed anymore.
Study objective
The objective of this study is to compare TNE with conventional upper GI
endoscopy in detecting esophageal mucosal abnormalities, effectiviness of
barrier for microorganisme and patients experience with both techniques.
Study design
To recruit patients for this study, the list of patients waiting for upper GI
endoscopy will be obtained. a total of 40 patients will be included
Patients will be asked to undergo a second endoscopy at the same time using the
TNE system. After each procedure, the tip of the TNE system will be cultured
Before and 1 week after the endoscopy, patients will fullout questionnaires
Intervention
Patients will undergo a second endoscopy using the TNE system before the
conventionall upper gastrointestinal endoscopy
Study burden and risks
There are no benefits for patients participating in this study.
The disadvantage of this study is that patients will be asked to undergo a
second endoscopy at the same time using the TNE system which takes 5 minutes.
Besides, they have to fullout some questionnaires.
Dr. Molewaterplein 40
3015 GD Rotterdam
Nederland
Dr. Molewaterplein 40
3015 GD Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
signed informent consent
age > or= 18 years
diagnostic upper GI endoscopy
Exclusion criteria
The following patients are excluded from the study:
a. Sedation is given to the patient
b. Unwilling to fullout the questionnaires
c. Therapeutic upper GI endoscopy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL12540.078.06 |