Actively Recruiting

All Genders
ID06803147

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

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

On this page

Sponsors

A

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Lead Sponsor

N

Nederlandse Barrett REgistratie Stichting

Collaborating Sponsor

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 Barrett's 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 Barrett's 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.

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histological diagnosis of non-dysplastic Barrett's esophagus (NDBE).
  • Barrett's esophagus segment with a maximum length of less than 5 cm.
  • At least one adequate, high-quality upper endoscopy performed per guidelines.
  • No recent history of low-grade dysplasia or indefinite for dysplasia in the past 2 years or last endoscopy.
  • No history of high-grade dysplasia or esophageal cancer.
  • Age between 55 and 75 years at inclusion.
  • Informed consent provided by the patient or legal guardian.
Not Eligible

You will not qualify if you...

  • Barrett's esophagus with current or past dysplasia, including prior cancer, prior high-grade dysplasia, or confirmed low-grade dysplasia or indefinite for dysplasia in the last 2 years or last endoscopy.
  • Presence of endoscopically visible lesions.
  • Active reflux esophagitis LA grade C or D.
  • Barrett's esophagus segment less than 1 cm in length with no surveillance indication.
  • Family history of esophageal adenocarcinoma in at least one first-degree relative.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 10 years

Participants who have discontinued endoscopic surveillance are followed over time to monitor clinical outcomes.

Periodic visits as per clinical guideline recommendations

Trial Site Locations

Total: 1 location

1

Antoni van Leeuwenhoek - Centrum voor Vroegdiagnostiek (Barrett Coordination Centre)

Amsterdam, Netherlands, 1066 CX

Actively Recruiting

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Research Team

S

Sanne SN van Munster, MD PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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