Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/01/2014
Date assigned
01/04/2014
Last edited
01/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The definition of the transition between esophagus and stomach (EGJ) for a diagnosis of Barrett’s 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

Contact information

Type

Scientific

Primary contact

Dr Bas Weusten

ORCID ID

Contact details

Koekoekslaan 1
Nieuwegein
3435 CM
Netherlands

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 Barrett’s 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 Barrett’s 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

Sponsor information

Organisation

St. Antonius Hospital (Netherlands)

Sponsor details

Prof Weusten
Koekoekslaan 1
Nieuwegein
3435 CM
Netherlands

Sponsor type

Not defined

Website

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

Publication citations

Additional files

Editorial Notes