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

Recruitingn/aAges any - anyAllAcademisch Medisch Centrum - Universiteit van Amsโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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

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๐Ÿ“‹ Eligibility rules (as published)
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\<5). * At least one adequate, high-quality upper endoscopy with assessment of the Barrett segment performed according to existing guidelines, as evaluated by the referring endoscopist. A high-quality endoscopy is defined as: adequate imaging with high-resolutoin endoscope with sampling performed according to the Seattle protocol, and in absence of LA grade C or D reflux esophagitis. The endoscopist determines whether the last endoscopy was of high-quality. If this was not the case, the endoscopist may decide to schedule a new encoscopy. * No recent history of confirmed indefinite for dysplasia (IND) or confirmed LGD, defined as no LGD and/or IND in the last 2 years and not in the last endoscopy.No history of HGD or cancer in BE * Age โ‰ฅ55 years and โ‰ค75 years at the moment of inclusion. * Informed consent provided by the patient or legal guardian. Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * BE with (history of) dysplasia, either: * Prior cancer * Prior HGD * Confirmed LGD or IND in the last 2 years or during the last endoscopy * Patients with an endoscopically visible lesion * Patients with active reflux esophagitis LA grade C or D * Patients with Barrett's esophagus with a maximum extent \<1cm in length with currently already no surveillance indication. * Patients with a family history of esophageal adenocarcinoma, defined as at least one first-degree relative with adenocarcinoma of the esophagus or gastric cardia.
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What it tests

  • Discontinued endoscopic surveillance
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Where

1 site
Antoni van Leeuwenhoek - Centrum voor Vroegdiagnostiek (Barrett Coordination Centre)
Amsterdam, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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