Detection of palisade vessels as a landmark of the end of Barrett's esophagus (BE)

ISRCTN ISRCTN18904979
DOI https://doi.org/10.1186/ISRCTN18904979
Secondary identifying numbers N/A
Submission date
27/01/2014
Registration date
01/04/2014
Last edited
24/01/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Bas Weusten
Scientific

Koekoekslaan 1
Nieuwegein
3435 CM
Netherlands

Study information

Study designProspective single center study
Primary study designObservational
Secondary study designOther
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleDetection of PALisade VESsels as a landmark for the distal Barrett’s esophagus in Western population
Study acronymPALVES
Study objectivesThe 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(s)Regional Medical Ethics Committee - United Committees for Human Research (Verenigde Commissies Mensgebonden Onderzoek), 27/04/2012, R12.003
Health condition(s) or problem(s) studiedBarrett's esophagus, endoscopy
InterventionTaking 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 typeOther
Primary outcome measureThe proportion of patients with visible palisade vessels using white light endscopic imaging and using Narrow Band Imaging (EXERA III endoscopy system)
Secondary outcome measures1. 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 study start date01/05/2012
Completion date01/07/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit80 Years
SexBoth
Target number of participants25 patients
Key inclusion criteria1. 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
Key exclusion criteria1. (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
Date of first enrolment01/05/2012
Date of final enrolment01/07/2013

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Koekoekslaan 1
Nieuwegein
3435 CM
Netherlands

Sponsor information

St. Antonius Hospital (Netherlands)
Not defined

Prof Weusten
Koekoekslaan 1
Nieuwegein
3435 CM
Netherlands

ROR logo "ROR" https://ror.org/01jvpb595

Funders

Funder type

Hospital/treatment centre

St. Antonius Hospital (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2016 24/01/2019 Yes No

Editorial Notes

24/01/2019: Publication reference added