To compare the yield of autofluorescence guided targeted biopsy versus four-quadrant random biopsy in the evaluation of patients with known occult neoplastic lesions in Barrett*s Esophagus.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The number of detected HGD/EC lesions in Barrett*s Esophagus in the FQRB by use
of video endoscopy compared to the number of detected lesion by the
autofluorescence guided targeted biopsy specimens.
Secondary outcome
1) The number of biopsy specimens needed to detect one HGD/EC lesion by the use
of AFE guided biopsy specimens.
2) The number of biopsy specimens needed to detect one HGD/EC lesion by the use
of video endoscopy FQRB.
3) Duration of the procedure for WLE, AF endoscopy and video endoscopy.
Background summary
Many centers recommend endoscopic surveillance for patients with BE to detect
Barrett*s neoplasia at an early, curable stage. It has been estimated that
early detection of esophageal adenocarcinoma, using endoscopic surveillance
regimens, can improve the cure rates from 20 to 76 %. The current gold standard
for endoscopic surveillance of BE entails taking biopsy specimens from each
endoscopically visible mucosal abnormality followed by random 4-quadrant
biopsies every 2 cm throughout the length of the BE, beginning at the proximal
end of the gastric folds proximally to the esophageal mucosa.
Random biopsy sampling with a conventional white-light endoscope is time
consuming, and is subject to a sampling error.Other endoscopic techniques are
currently under investigation to improve detection of early lesions, primarily
through targeting of biopsy sampling. High - resolution endoscopy has shown to
be sensitive for the visualisation of early mucosal abnormalities. However,
even with the most advanced endoscopes, high-grade dysplasia or early carcinoma
is not always visible in the esophageal mucosa and the risk for undetected
dysplastic or malignant lesions is still present.
Autofluorescence endoscopy (AFE) is based on the presence of endogenous
molecules (fluorophores) such as collagen, nicotinamide adenine dinucleotide,
and porphyrins, in the mucosa. These molecules can emit fluorescence light of a
longer wavelength when excited with short- wavelength light (typically blue
light).Tissue alterations as in neoplasia may change the concentration and
spatial distribution of the various endogenous fluorophores and consequently
alter the tissue autofluorescence.AFE enables rapid screening of large surface
areas of mucosa and has been shown to improve detection of dysplastic lesions
in the colon, especially small lesions, early stage lesions and flat or
depressed adenomas. Application of AFE in screening of Barrett*s mucosa has so
far been limited by a high rate of false- positive findings, which is probably
due to changes attributable to active inflammation.However, published studies
evaluating the value of autofluorescence endoscopy in the detection of early
esophageal neoplasia have been performed with a video AFE system that is less
sensitive for the weak autofluorescence signal than our AFE system.
Study objective
To compare the yield of autofluorescence guided targeted biopsy versus
four-quadrant random biopsy in the evaluation of patients with known occult
neoplastic lesions in Barrett*s Esophagus.
Study design
page 3 protocol: flow chart
Study burden and risks
Esophagoscopy is considered to be a low risk intervention
s-Gravendijkwal 230
3015 CE Rotterdam
Nederland
s-Gravendijkwal 230
3015 CE Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
Patients age >= 18 years scheduled for endoscopy because of recently diagnosed random HGD/EC lesions in Barrett*s Esophagus.
Exclusion criteria
* Patients unable or unwilling to give informed consent
* Coagulopathy uncorrected at the time of endoscopy or thrombocytopenia (<50 x 109 / l thrombocytes)
* Patients with active reflux esophagitis
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 | NL21543.078.08 |