Status:
NOT_YET_RECRUITING
EMR Versus ESD for Barrett's Neoplasia
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
University Medical Center Groningen
Amsterdam UMC, location VUmc
Conditions:
Barretts Esophagus With Dysplasia
Barrett Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
331 Patients enrolled
Trial Details
Trial ID
NCT05276791
Start Date
December 1 2022
End Date
December 1 2026
Last Update
July 21 2022
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