Health Trials

About this trial

Rationale:

The optimal technique for removal of visible dysplastic lesions in Barrett's esophagus remains controversial. Endoscopic mucosal resection (EMR) is safe, effective, easy to apply, and has been the most widely used technique since 2008. Endoscopic submucosal dissection (ESD) is a more controlled dissection method with potential improved efficacy, but at the cost of higher technical complexity.

Objective:

The investigators aim to compare EMR and ESD for removal of visible lesions in Barrett's esophagus.

Study design:

Randomized clinical trial

Study population:

Patients with Barrett's esophagus and a visible lesion with dysplasia and/or early cancer. Suspicion for submucosal invasion is an exclusion criterion.

Intervention:

Patients are randomized to receive either EMR or ESD, with follow-up and no ablation during 12 months after the resection.

Main study endpoint:

Primary endpoint is the proportion of patients with no evidence of residual or local recurrent neoplasia during 12 months follow-up after baseline.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • EMR
  • ESD

Treatment groups

331 Participants
are divided into 2 treatment groups

Locations

6
Amsterdam University Medical Center Amsterdam Netherlands
Catharina Ziekenhuis Eindhoven Netherlands
University Medical Center Groningen Groningen Netherlands
St. Antonius Ziekenhuis Nieuwegein Netherlands

Sponsors and collaborators

St. Antonius Hospital

Lead sponsor

University Medical Center Groningen

Collaborator

Erasmus Medical Center

Collaborator

UMC Utrecht

Collaborator

Amsterdam University Medical Center

Collaborator

Catharina Ziekenhuis Eindhoven

Collaborator

Source ClinicalTrials.gov