Stopping routine endoscopic surveillance for low-risk Barrett's esophagus (BLISS Project)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The BLISS Project is an observational program that follows patients with non-dysplastic Barrett's esophagus and a short Barrett segment (M < 5 cm) after they discontinue routine endoscopic surveillance. Eligible participants must have had at least one recent high-quality endoscopy with Seattle-protocol sampling and no confirmed low-grade dysplasia or indefinite for dysplasia in the past two years. The project will monitor for the incidence of clinically significant esophageal adenocarcinoma and related outcomes over time to determine whether stopping surveillance leads to a meaningful increase in advanced cancers. This work is motivated by recent Dutch guideline changes that recommend stopping surveillance for selected low-risk patients in the absence of strong evidence of survival benefit from routine endoscopy.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Sanne SN van Munster, MD PhD
• Email: s.n.vanmunster@amsterdamumc.nl
• Phone: 0031613396146

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.