To assess the usefulness of NBI in the visualisation of PVs in Western BE patients (in this study using the new Excera III NBI-system), to investigate the discordance between the Japanese and Western definition of de distal end of the Barrett*s…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) To investigate the feasibility of NBI for the detection of PVs in Western BE
patients, using the new Olympus Excera III endoscopy system,
2) Compare the yield of NBI in the detection of PVs with that of white light
videoendoscopy.
Secondary outcome
1) To elucidate the optimal endoscopic condition to visualize the distal end of
PVs.
2) To evaluate the discordance in the distal margin of BE using two different
landmarks.
3) To assess the clinical relevance of this discordance by evaluating the
presence of intestinal metaplasia on biopsies taken from the area of
discordance.
4) To assess the interobserver variability for the location of the distal
margin of the Barrett epithelium using the palisade vessels as a landmark, and
compare this with the interobserver variability of the location of the distal
margin of the Barrett*s epithelium using the top of the gastric folds as a
landmark.
Background summary
The incidence of Barrett*s related esophageal adenocarcinoma is gradually
increasing worldwide. However, discrepancies exist in the endoscopic definition
of Barrett*s Esophagus (BE) between the Western world and Japan. According to
the Western criteria, the distal end of the BE is defined by the proximal end
of gastric folds, whereas in Japan the distal end of palisade vessels (PVs)
defines the distal margin of the BE. PVs are thought to be rather faint, or
even absent in a significant proportion of Western BE patients. Consistency in
the definition of BE is thought to be essential for better understanding and
further investigation of BE. The use of Narrow Band Imaging (NBI), one of
image-enhancing endoscopic modalities, makes vessels more readily visible and
enhances contrast in mucosal structures and vesels, and may therefore help to
show PVs clearly. The new Olympus Excera III endoscopy system combines bright
NBI with dual focal high-resolution endoscopy, and may in this study more
easily recognize and visualize PVs, even in Western BE patients.
Study objective
To assess the usefulness of NBI in the visualisation of PVs in Western BE
patients (in this study using the new Excera III NBI-system), to investigate
the discordance between the Japanese and Western definition of de distal end of
the Barrett*s segment, to evaluate the clinical relevance of this discordance,
and to study the interobserver variability of both Western and Japanese
criteria.
Study design
Prospective, mono-center, single arm, not randomised.
Study burden and risks
The burden for the patients is negligible because the patients are scheduled
for upper endoscopy as part of normal clinical care (no additional endoscopies
will be performed). This study needs additional five minutes for recording with
photos/video and for taking additional biopsies.
Koekoekslaan 1
3435CM Nieuwegein
NL
Koekoekslaan 1
3435CM Nieuwegein
NL
Listed location countries
Age
Inclusion criteria
1) Age 18-80 years
2) BE with a minimum length of C2M2 (segment of minimally 2 cm circumferential Barrett epithelium) as pointed by prior endoscopic examination(s)
3) Subject who agrees to participate, fully understands the content of the informed consent form, and signs the informed consent form
Exclusion criteria
1) (Previous) biopsies showed high grade dysplasie or early adenocarcinoma of the distal 2 cm of the esophagus.
2) Prior endoscopic treatment for BE or Barrett*s dysplasia/cancer (e.g. radiofrequency ablation, endoscopic mucosal resection, multi-band mucosectomy)
3) Prior surgical intervention for the lower part of the esophagus or the upper part of the stomach
4) Subject being pregnant or planning a pregnancy
5) Esophageal stricture preventing passage of endoscope
6) Subject suffering from unstable psychiatric disorder(s)
7) Subject unable to give the informed consent
8) Uncorrectable clotting disorders, esophageal varices, or other conditions precluding taking biopsies
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 | NL39542.100.12 |