Plain English Summary
Background and study aims
The definition of the transition between esophagus and stomach (EGJ) for a diagnosis of Barretts esophagus (BE) is not uniform: in Western guidelines the EGJ is located at the top of the gastric folds (GF) in expiration. In contrast, in Japan the EGJ is defined by the distal end of the palisade vessels (PV), little vessels perforating the mucosa in the distal esophagus. Yet, PV are faint and often poorly visible in Western patients. Narrow Band Imaging (NBI) enhances contrast in mucosal structures and vessels. The new Olympus EXERA III endoscopy system combines bright NBI with dual focal high-resolution endoscopy, and may more easily visualize PV, even in Western BE patients. The aim of the study is to evaluate the detection rate of PV using the EXERA III system, to quantify the discordance between the Western and Japanese criteria for the distal border of BE, and to evaluate the presence of intestinal metaplasia (IM) in this zone of discordance (ZoD), in Western BE patients.
Who can participate?
All BE patients scheduled for surveillance endoscopy.
What does the study involve?
For this study additional images of the EGJ are taken for further analyses. In case of a zone of discordance, biopsies are taken from this zone. Furthermore routine biopsying is performed for surveillance of BE.
What are the possible benefits and risks of participating?
There are no benefits in participating. In patients with a zone of discordance 2 extra biopsies are taken, with accompanying risks.
Where is the study run from?
St. Antonius Hospital, Nieuwegein, the Netherlands.
When is the study starting and how long is it expected to run for?
The study started in May 2012 and finished in June 2013.
Who is funding the study?
St. Antonius Hospital, Nieuwegein, the Netherlands.
Who is the main contact?
Dirk Schölvinck
d.scholvink@antoniusziekenhuis.nl
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Detection of PALisade VESsels as a landmark for the distal Barretts esophagus in Western population
Acronym
PALVES
Study hypothesis
The improved Narrow Band Imaging endoscopy system (EXERA III) may more easily facilitate the detection of palisade vessels (PV) in the Western BE population, and enable a comparison between the Western and Japanese criteria for the distal BE. The aim of this study was therefore to prospectively evaluate the detection rate of palisade vessels using NBI (EXERA III system), to quantify the discordance between the Western and Japanese criteria for the distal border of the BE, and to evaluate the clinical relevance of this discordance.
Ethics approval
Regional Medical Ethics Committee - United Committees for Human Research (Verenigde Commissies Mensgebonden Onderzoek), 27/04/2012, R12.003
Study design
Prospective single center study
Primary study design
Observational
Secondary study design
Other
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Barrett's esophagus, endoscopy
Intervention
Taking biopsies from the discordant area to make a histological diagnosis of BE. Based on realtime endoscopy, endoscopic images and biopsies we try to assess the visibility of palisade vessels and the possible implications when these palisade vessels are not located at the same level of the gastric folds.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The proportion of patients with visible palisade vessels using white light endscopic imaging and using Narrow Band Imaging (EXERA III endoscopy system)
Secondary outcome measures
1. The proportion of patients with visible PVs with or without air inflation, and in a forward view or a retroflex view
2. The degree of discordance between the location of the proximal ends of the gastric folds and the distal end of the PVs
3. The degree of discordance in the location of the proximal ends of the gastric folds between the condition with and without air inflation
4. The proportion of biopsies containing intestinal metaplasia on histological evaluation among the BE area, the area of discordance (area between the top of gastric folds and distal end of PVs), and the gastric area (area just below the distal ends of PVs)
5. The interobserver agreement for the rates of visualisation of PVs and the top of the gastric folds on each condition
Overall trial start date
01/05/2012
Overall trial end date
01/07/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age 18-80 years
2. BE with a minimum length of circumferential/ maximal (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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
25 patients
Participant exclusion criteria
1. (Previous) biopsies of the most distal 2 cm Barrett esophagus (according to CM-classification) showed high grade dysplasia or esophageal adenocarcinoma (EAC)
2. Prior endoscopic treatment for BE or Barretts dysplasia/cancer (e.g. radiofrequency ablation, endoscopic mucosal resection, multi-band mucosectomy
3. Prior surgical invervention 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
Recruitment start date
01/05/2012
Recruitment end date
01/07/2013
Locations
Countries of recruitment
Netherlands
Trial participating centre
Koekoekslaan 1
Nieuwegein
3435 CM
Netherlands
Funders
Funder type
Hospital/treatment centre
Funder name
St. Antonius Hospital (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary