Actively Recruiting
Care Evaluation of Low-Risk Barretts Esophagus Patients Stopping Endoscopic Surveillance The BLISS Project Observational Study
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-10-03
3156
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term outcomes of stopping endoscopic surveillance in patients with low-risk non-dysplastic Barretts esophagus NDBE. This observational study aims to determine whether discontinuing surveillance leads to an increase in clinically significant esophageal adenocarcinoma EAC, focusing on patients with Barretts esophagus less than 5 cm in length, no history of dysplasia, and no family history of EAC. The study is a nationwide, prospective, single-arm project in the Netherlands with a minimum follow-up duration of 10 years. In this study, endoscopic surveillance is discontinued following new Dutch guideline recommendations for eligible low-risk NDBE patients. Participants are then monitored through existing national registries and medical records without additional procedures or interventions. Two patient groups will be analyzed separately those with prior surveillance history and those newly diagnosed with NDBE at inclusion. Data collection involves pathology reports, national statistics, and cancer registries, with outcomes reviewed annually by a data safety monitoring board. Participants provide informed consent to be included in the registry, but no active involvement or changes to their care are required beyond standard practice. Researchers will track the incidence of clinically apparent EAC, defined by EAC-related death or EAC requiring palliative or non-curative treatments, over at least 10 years. Privacy protections and ethical standards are carefully maintained throughout the study to minimize risks and ensure confidentiality.
CONDITIONS
Brief Title
"Less-is-more in Barrett-surveillance" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillance is Stopped. The BLISS Project.
Research Team
S
Sanne SN van Munster, MD PhD
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