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Compares treatment options for Barretts Esophagus With Dysplasia
Official title EMR Versus ESD for Barrett's Neoplasia
ClinicalTrials.gov ID: NCT05276791
What this study is testing
- What it's testing
- 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.
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Multiple lesions are allowed as long as the lesions are considered eligible for endoscopic treatment. Only the target lesion is evaluated for the...
You likely can't join if
- 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...
- History of esophageal surgery other than fundoplication
- History of esophageal ablation therapy
- 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
See the full eligibility 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
- 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
- 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 instructions, or follow-up guidelines
- Life expectancy \<2 years
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
- Eindhoven, Netherlands
- Groningen, Netherlands
- Nieuwegein, Netherlands
- Rotterdam, Netherlands
- Utrecht, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands; Eindhoven, Netherlands; Groningen, Netherlands; Nieuwegein, Netherlands; Rotterdam, Netherlands; Utrecht, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.