EMR vs. ESD for Barrett's lesions with dysplasia or early cancer

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

In this randomized trial, adults with Barrett's esophagus and a visible lesion are assigned to either endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) to remove the lesion, with 12 months of follow-up and no ablation during that period. The main goal is to see what proportion of patients have no residual or locally recurrent neoplasia after treatment. Participants must have no signs of submucosal invasion and must be willing to undergo either procedure. Prior endoscopic resections are allowed, and the study is conducted across multiple centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients age: ≥ 18 years
* Willingness to undergo both EMR or ESD
* Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation
* BE with at least one visible lesion ("target lesion") with absence of signs of submucosal invasion on endoscopy, after evaluation by the adjudication committee
* Multiple lesions are allowed as long as the lesions are considered eligible for endoscopic treatment. Only the target lesion is evaluated for the study
* Prior endoscopic resection is allowed

Exclusion Criteria:

* Patients with visible lesions with suspicion of submucosal invasion based on assessment of the adjudication committee
* Patients with HGD in at least one random biopsy, before inclusion (i.e. during endoscopy in the referring center \<3 months before imaging, or during imaging endoscopy)
* History of esophageal surgery other than fundoplication
* History of esophageal ablation therapy
* In case of prior endoscopic resection, the target lesion located within 1 cm of the prior resection site
* Uncontrolled coagulopathy with INR \>2.0, thrombocytopenia with platelet counts \< 50,000
* Esophageal varix or varices
* Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines
* Life expectancy \<2 years

Where it's running

• Amsterdam University Medical Center
  Amsterdam, Netherlands Recruiting
• Catharina Ziekenhuis
  Eindhoven, Netherlands Recruiting
• University Medical Center Groningen
  Groningen, Netherlands Recruiting
• St. Antonius Ziekenhuis
  Nieuwegein, Netherlands Recruiting
• Erasmus Medical Center
  Rotterdam, Netherlands Recruiting
• University Medical Center Utrecht
  Utrecht, Netherlands Recruiting

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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.