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

September 30, 2025 updated by: Sanne van Munster, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

"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 <5cm in length; (2) without (a history of) dysplasia; and (3) without a family history for EAC. A family history of EAC is defined as at least one first-degree relative with esophageal cancer.

Main study parameters/endpoints:

Primary study endpoint: the annual incidence of patients with clinically apparent EAC during a minimum follow-up of 10 years. Clinically apparent EAC is defined as one of the following:

  • EAC related death, and/or
  • EAC that exceeds boundaries for curative endoscopic treatment, defined as any symptomatic EAC that undergoes (1) palliative treatment; (2) esophagectomy; (3) chemotherapy; (4) radiotherapy; (5) immunotherapy; and/or (6) non-endoscopic therapy otherwise.

Two separate cohorts will be identified; (1) patients with an endoscopic surveillance history at the moment of study inclusion; and (2) patients with newly diagnosed NDBE at the moment of study inclusion. The primary endpoint will be evaluated separately in both cohorts. The power calculation will be based on the primary endpoint evaluation only in cohort 2, since cohort 1 is prone to selection bias.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

This registry that evaluates outcomes of regular clinical care, imposes minimal burden on participants. Subjects are not exposed to procedures or interventions. Data collection is based on existing national databases and medical records. Participants will provide informed consent for inclusion in the database, to ensure that patients understand the study's scope and their rights, with no further obligations for active involvement. Of note, discontinuation of endoscopic surveillance is standard practice according to the guideline. The current studies passively evaluates the outcomes, and patients only provide informed consent for inclusion in the registry. If a patient does not sign the informed consent form, the patient is not included in the registry, still, endoscopic surveillance for this patient will be discontinued.

Also robust measures will be implemented to ensure strict adherence to data protection regulations and safeguard participants' privacy and confidentiality. The primary focus remains on upholding ethical standards and minimizing any potential risks to participants while still be able to monitor relevant outcomes

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Recruiting
        • Antoni van Leeuwenhoek - Centrum voor Vroegdiagnostiek (Barrett Coordination Centre)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with low-risk Barrett esophagus

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical esophageal adenocarcinoma
Time Frame: 10 years
Number of patietns with EAC related death, and/or EAC exceeding boundaries for endoscopic treatment EAC that exceeds boundaries for curative endoscopic treatment, defined as any symptomatic EAC that undergoes (1) palliative treatment; (2) esophagectomy; (3) chemotherapy; (4) radiotherapy; (5) immunotherapy; and/or (6) non-endoscopic therapy otherwise.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nederlandse Barrett REgistratie Stichting

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 7, 2038

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 7, 2038

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BLISS01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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