Condition: Barrett Esophagus · Barrett Esophagus Adenocarcinoma · Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Rationale: Until recently, the conventional strategy outlined by both national and international guidelines for managing non-dysplastic (ND) Barrett esophagus (BE), involved endoscopic surveillance at 3 to 5 year intervals, aiming to reduce mortality from esophageal adenocarcinoma (EAC) through early detection and treatment. However, scientific evidence that supports the benefits in EAC-specific and/or overall survival, or that shows cost-effectiveness, is lacking. This has led to a re-evaluation of surveillance practices, particularly for NDBE patients at low risk of progression to EAC. For this reason, and in light of the 'NVMDL knowledge agenda,' a recent adjustment has been made to the Dutch guideline, recommending discontinuation of endoscopic surveillance for low-risk NDBE patients, hypothesizing that discontinuing endoscopic surveillance in low-risk NDBE patients will not lead to a relevant increase in the incidence of clinically significant EAC. This study aims to evaluate long-term outcomes of this guideline change. Objective: The primary objective is to evaluate the incidence of clinically apparent EAC after discontinuation of endoscopic surveillance in low-risk NDBE patients. Study design: This is a nationwide, prospective, single-arm observational study with a minimum duration of 10 years. All patients in the Netherlands, eligible for study participation, will be approached and, upon signing informed consent, included in this care evaluation project. Baseline …
This description comes directly from the study's public registry record.
Sanne SN van Munster, MD PhD · 0031613396146 · s.n.vanmunster@amsterdamumc.nl
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| Antoni van Leeuwenhoek - Centrum voor Vroegdiagnostiek (Barrett Coordination Centre) | Amsterdam, Netherlands | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06803147