Determine the technical success, diagnostic accuracy, safety and quality of procedure (evaluated by the endoscopist) of the E.G.Scan* compared to conventional upper endoscopy in patients referred for diagnostic upper endoscopy.
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diagnostic accuracy of procedure as determined by sensitivity and specificity
for upper GI lesions.
Secondary outcome
To determine
- technical success
- safety
- quality of procedure (evaluated by the endoscopist)
of the E.G.Scan* compared to conventional upper endoscopy in patients referred
for diagnostic upper endoscopy.
Background summary
Upper gastrointestinal (GI) endoscopy is the procedure of choice for the
diagnosis and treatment of upper GI disorders. Since costs but also
complications of upper endoscopy are related to sedation, efforts have been
made to improve the tolerance for upper endoscopy and to reduce the need for
sedation. Small-caliber endoscopes have been developed which can be introduced
through the mouth or nose without the need for sedation. Several large studies
have been conducted with regard to tolerance, safety, feasibility and accuracy
of unsedated small-caliber transnasal upper endoscopy. Recently a new endoscopy
system, the E.G.Scan*, has been developed which is compact and is partly
disposable. For this design endoscope, there is no need for the laborious and
costly process of cleansing and desinfection, which needs to be done with a
standard endoscope. Besides, the E.G.Scan* can be used outside the endoscopy
unit, which allows upper endoscopy outside the hospital.
Study objective
Determine the technical success, diagnostic accuracy, safety and quality of
procedure (evaluated by the endoscopist) of the E.G.Scan* compared to
conventional upper endoscopy in patients referred for diagnostic upper
endoscopy.
Study design
Fully paired diagnostic accuracy study.
Intervention
Transnasal upper endoscopy performed with the E.G.Scan* (IntroMedic Co., Ltd.,
Seoul, Korea) followed by conventional upper endoscopy.
Study burden and risks
The potential benefit for patients is a better overall tolerance of the
procedure and performance of upper endoscopy outside the hospital. In addition,
direct and indirect costs associated with upper endoscopy can be saved as it
can be imagined that in the future, patients can undergo upper endoscopy in an
outpatient setting or even by a specialized general practitioner. The burden
consists of undergoing an additional upper endoscopy , which takes
approximately 10-20 minutes. Patients will be contacted 1 week and 1 month
after the procedure to obtain information about possible complications (5
minutes). No additional study visits are necessary. The risk associated with
participation is pain in the nasopharyngeal area, (self-limiting), epistaxis
(0% - 22.6%) or vasovagal collaps (0%- 0.3%).
Postbus 85500
3508 GA Utrecht
NL
Postbus 85500
3508 GA Utrecht
NL
Listed location countries
Age
Inclusion criteria
- Indication for diagnostic upper endoscopy
- Age older than 18 years
- Written informed consent
Exclusion criteria
- Therapeutic endoscopic intervention (e.g. polypectomy)
- Reduced general condition (ASA III-IV)
- Known bleeding diathesis
- Conurrent anticoagulation therapy
- Significant history of trauma/surgery of nose or nasal cavity
- Recurrent epistaxis (> 1 episode/3month)
- Changed anatomy of the upper gastrointestinal tract due to surgery of the esophagus,
stomach and duodenum.
- Implantable pacing devices
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 | NL37696.041.11 |