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

Detection of palisade vessels as a landmark of the end of Barrett's esophagus - PALVES

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37487

Enrollment

Registered

2012-04-27

Start date

2012-06-14

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal metaplasia precursor of esophageal cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results