Barrett esophagus
Conditions
Interventions
None listed
Sponsors
St. Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria: - Patients with visible lesions with suspicion of submucosal invasion bases 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 or endoscopic resection - 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 in-structions, or follow-up guidelines - Life expectancy <2 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the proportion of patients with no evidence of residual or local recurrent neoplasia of the target lesion during 12 months follow-up after baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Incidence of local residual and/or local recurrent neoplasia in patients with a visible lesion =15mm - Incidence of perforation - Incidence of post-procedural bleeding - Incidence of esophageal stenosis - Procedure times - Proportion of patients with endoscopically radical resection - Cost-effectiveness - Total number of ER endoscopies per patient - Proportion of patients with (progression to) high-risk EAC - Proportion of patients in whom additional non-endoscopic therapy is required | — |
Countries
Australia, Belgium, France, Germany, Netherlands, United Kingdom
Contacts
Public ContactB.L.A.M. Weusten
St. Antonius Ziekenhuis
Outcome results
None listed