Does ETMI improve the dysplasia in Barrett's esophagus?
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of patients detected with dysplasia.
Number of lesions detected with dysplasia.
Secondary outcome
Positive predictive value of high-resolution white light endoscopy and
autofluorescence imaging.
Reduction of fals-positive findingfs with narrow band imaging.
Background summary
Barrett's esophagus is a premalignant disease. Dysplastic change occur in a
sequential order from low garde dysplasia - high grade dysplasia - intramucosal
carcinoma and finally to advanced esophageal adenocarcinom. Patients with
Barrett's esophagus undergo regular endscopic surveillance for the detection of
dysplasia. Dysplatic lesion are, however difficult te detect with standard
endoscopy techniques.
A new prototype, Endoscopic TriModal Imaging, incorperates high-resolution
white light endoscopy, autofluorescence imaging and narrow band imaging in one
systeem. Autofluorescence imagnig excites the esophagus with blue light. The
mucosa fluorescence and normal tissue has a different fluorescent spectrum than
dysplatic tissue. In uncontrolled studies it was found that autofuorescence may
improve the detection of dysplasia. this technique was however also associated
with fals-positiv findings. Narrow band imaging is a novel technique that makes
use special light filters that improve the imaging of superficial mucosal
structures and bloodvessels in the mucosa. Regular mucosal and vascular
patterns are associated with non-dysplatic Barrett's and irregular patterns
with dysplatic Barrett's. After the detection of suspicious areas with
autofluorescence narrow band imaging can used for the detailed inspection of
these area and thus subsequently lower the number of fals positive findings.
Patients with a early detected dysplatic/neoplatic lesion(s) can treated
curative endoscopically, making an esophagectomy obsolete.
Study objective
Does ETMI improve the dysplasia in Barrett's esophagus?
Study design
A randomised cross-over multi-center study. Patients will undergo two
endoscopies, one with ETMI and with the standard technique. Both procuderes
will be coonducted by two different endoscopists.
Study burden and risks
An endoscopic procedure is safe. Most complications are related with the
sedation during the procedure. Total morbodity of a gastroscopy is between
0.14% and 0.20%. Mortality is 0.07%. The additional risk of a second procedure
is very small.
Meibergdreef 9
1105 AZ
Nederland
Meibergdreef 9
1105 AZ
Nederland
Listed location countries
Age
Inclusion criteria
Age >18 years
Prior diagnosis of Barrett's esophagus
Minimum Barrett's length of C>2M>2 or C<2M>4 according to the Prague C&M classification
Written informed consent
Exclusion criteria
Presence of esophagitis > grade A according to the LA classification of erosive esophagitis
Presence of conditions precluding histological sampling of the esophagus
Design
Recruitment
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 | NL15477.018.06 |