Actively Recruiting
A Multicenter Prospective Cohort Study Comparing Random Biopsies Versus Wide-Area Transepithelial Brush-Sampling for Surveillance of Barrett's Esophagus
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2022-12-08
416
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are investigating the development of high-grade dysplasia (HGD) and esophageal adenocarcinoma (EAC) in patients with Barrett's Esophagus (BE). This study compares the traditional random biopsy method with a new Wide-Area Transepithelial Brush-Sampling (WATS) technique to improve detection during surveillance. The study focuses on two groups: those at high risk after removal of visible lesions or low-grade dysplasia and those under routine BE surveillance without dysplasia. Participants will undergo baseline and follow-up endoscopies over three years where both random biopsies and WATS brushings are performed. The WATS brush samples cells from all epithelial layers using a specialized cytology brush passed through the endoscope. This method is being studied for its potential to detect dysplasia earlier and more thoroughly than traditional biopsies. Samples collected will also support future biomarker research to better predict disease progression. During the study, participants will have regular endoscopic exams with combined biopsy and brush sampling to monitor for the appearance of HGD or EAC. Researchers will analyze biopsy results, WATS findings, and patient outcomes over the three-year follow-up. Safety and procedure effectiveness will be assessed, and the study allows for specimen collection to explore new diagnostic markers. The total participation duration is three years, with ongoing monitoring to understand the natural history of cases identified by WATS but not by biopsy.
CONDITIONS
Brief Title
A Multicenter Prospective Cohort Study Comparing Random Biopsies Versus Wide-Area Transepithelial Brush-Sampling (WATS) for Surveillance of Barrett's Esophagus, the WATS-EURO2 Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Barrett's Esophagus with circumferential extent of 2 cm or more and total maximum extent of 18 cm, or 0-1 cm circumferential extent with maximum extent of 4 cm
- Cohort 1: Patients referred for work-up of indefinite, low-grade, high-grade dysplasia, or low-risk esophageal cancer diagnosed within 18 months prior to baseline
- Cohort 2: Patients with Barrett's Esophagus without dysplasia diagnosis in the last 18 months enrolled in surveillance
- Ability to provide written informed consent and understand study participation responsibilities
You will not qualify if you...
- Visible lesions in the esophagus at the time of testing (prior endoscopic resection allowed)
- High-risk cancer after endoscopic resection (sm2/3 invasion, poor differentiation, lympho-vascular invasion, or positive resection margin)
- Endoscopy with biopsies or endoscopic resection within six weeks prior
- History of esophageal or gastric surgery other than Nissen fundoplication
- History of esophageal ablation therapy
- Presence of esophageal varices
- Known unresolved drug or alcohol dependency limiting consent or follow-up understanding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline visit
Participants undergo endoscopic evaluation with both random biopsies and WATS brushing to detect dysplasia or early cancer.
1 baseline visit (in-person)
Duration - Up to 3 years
Participants are followed with endoscopic surveillance combining biopsy and WATS brushing to monitor for development of high-grade dysplasia or esophageal adenocarcinoma over time.
Regular endoscopic follow-up visits over 3 years
Trial Site Locations
Total: 1 location
1
Amsterdam University Medical Centre, loc. VUmc
Amsterdam, North Holland, Netherlands, 1081HV
Actively Recruiting
Research Team
P
Pim Stougie
L
Lucas C Duits, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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