Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
331 participants
INTERVENTIONAL
2022-12-01
2026-12-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Endoscopic submucosal dissection
ESD
Endoscopic submucosal dissection, according to standard care
Endoscopic mucosal resection
EMR
Endoscopic mucosal resection, according to standard care
Interventions
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EMR
Endoscopic mucosal resection, according to standard care
ESD
Endoscopic submucosal dissection, according to standard care
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Medical Center Groningen
OTHER
Amsterdam UMC, location VUmc
OTHER
Erasmus Medical Center
OTHER
UMC Utrecht
OTHER
Catharina Ziekenhuis Eindhoven
OTHER
St. Antonius Hospital
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Sanne van Munster
Principal Investigator (Bas Weusten)
Other Identifiers
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001
Identifier Type: -
Identifier Source: org_study_id
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