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

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Jan 26, 2025

Keywords

ClinConnect Summary

The BLISS Project is a clinical trial that is looking at whether low-risk patients with Barrett's esophagus (BE) can safely stop undergoing regular endoscopic surveillance, which is a procedure used to monitor the condition. Traditionally, patients with non-dysplastic Barrett's esophagus have been advised to have these checks every 3 to 5 years to catch potential cancer early. However, recent guidelines suggest that for certain low-risk patients—those without dysplasia (abnormal cells), with a Barrett's segment less than 5 cm, and no family history of esophageal cancer—this monitoring may not be necessary. The trial aims to see if stopping surveillance for these patients will not lead to an increase in serious cases of esophageal adenocarcinoma (a type of cancer).

To participate in this study, individuals must be between 55 and 75 years old and have a confirmed diagnosis of non-dysplastic Barrett's esophagus. They should also have had a high-quality endoscopy in the past and no history of dysplasia or esophageal cancer. Participants will not undergo any new treatments or procedures; instead, their existing medical records will be used to gather information over a minimum of 10 years to assess the outcomes. Importantly, the study aims to maintain patient privacy and adhere to strict data protection regulations. If patients choose not to participate, their regular monitoring will still be stopped according to the new guidelines.

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Eligibility criteria

• 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 ≥55 years and ≤75 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.