"Less-is-more in Barrett-surveillance" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillance is Stopped. The BLISS Project.

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 information will be collected from endoscopy and pathology reports and the electronic patient files. During follow-up, data will be collected from existing registries, including the national pathology database named Pathologisch-Anatomisch Landelijk Geautomatiseerd Archief (PALGA), the national statistics database named: Central Bureau van Statistiek (CBS), Integraal Kankercentrum Nederland (IKNL), and if necessary, additional information will be collected from electronic patient files in patient's hospital or the general practitioner. On an annual basis, study outcomes will be evaluated and reviewed by a DSMB according to pre-defined stopping rules. Study population: All low-risk NDBE patients in the Netherlands in whom endoscopic surveillance will no longer be indicated based on the new Dutch guideline recommendations will be included. This includes patients with (1) BE with a maximum extent \

Inclusion Criteria: In order to be eligible to be included in this study, a subject must meet all of the following criteria: * Histological diagnosis of non-dysplastic Barrett's esophagus (NDBE). * Barrett's esophagus segment with a maximum length of less than 5 cm (Prague classification M\