What is this study trying to find out about Barrett's Esophagus?

This study aims to understand how often patients with Barrett's Esophagus develop high-grade dysplasia or esophageal cancer during surveillance. It compares the standard random biopsy method with a new brush sampling technique to see if the brush can better detect early disease. The research is led by the Academic Medical Center at the University of Amsterdam.

Who may be eligible for this Barrett's Esophagus clinical trial?

Adults aged 18 years or older with Barrett's Esophagus are eligible. The study includes those with recent diagnoses of dysplasia or early cancer, and those under routine surveillance without recent dysplasia. Anyone with visible lesions currently, recent major esophageal surgery, or certain medical dependencies may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this Barrett's Esophagus clinical trial?

Study-related care, including the study procedures and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for their travel needs.

Actively Recruiting

Age: 18Years +

All Genders

ID05642338

Comparing Random Biopsies and Wide-Area Brush-Sampling for Barretts Esophagus Surveillance A Multicenter Prospective Study on Detection of High-Grade Dysplasia and Esophageal Adenocarcinoma

Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2022-12-08

416

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating the development of high-grade dysplasia HGD and esophageal adenocarcinoma EAC in patients with Barretts 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

Age: 18Years +

All Genders

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

Research Team

Pim Stougie

Lucas C Duits, MD, PhD

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