Endoscopic Mucosal Resection Versus Endoscopic subMucosal Dissection fOr Removal of Visible Lesions in Barrett's Esophagus With Early Neoplasia: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Barretts Esophagus With Dysplasia
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Enrollment
- 331
- Primary Endpoint
- Primary endpoint is the proportion of patients with no evidence of residual or local recurrent neoplasia during 12 months follow-up after baseline.
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Sanne van Munster
Principal Investigator (Bas Weusten)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Eligibility 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 a single visible lesion with absence of signs of submucosal invasion on endoscopy, after evaluation by the adjudication committee.
Exclusion Criteria
- •Patients with visible lesions with suspicion of submucosal invasion bases on assessment of the adjudication committee
- •History of esophageal surgery other than fundoplication
- •History of esophageal ablation therapy or endoscopic resection
- •Multiple visible lesions in the BE segment at baseline
- •Uncontrolled coagulopathy with INR \>2.0, thrombocytopenia with platelet counts \< 50,000
- •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
Outcomes
Primary Outcomes
Primary endpoint is the proportion of patients with no evidence of residual or local recurrent neoplasia during 12 months follow-up after baseline.
Time Frame: 12 months
Secondary Outcomes
- Cost-effectiveness(12 months)
- Additional histopathologic evaluation may be performed to evaluate potential differences between the two techniques.(12 months)
- Incidence of complications(12 months)
- Procedure times(12 months)
- Proportion of patients with endoscopically radical resection(12 months)
- The total number of ER endoscopies per patient(12 months)
- The proportion of patients that shows neoplastic progression(12 months)