| NCT ID | NCT05276791 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Antonius Hospital |
| Condition | Barretts Esophagus With Dysplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 331 participants |
| Start Date | 2023-01-17 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 331 participants in total. It began in 2023-01-17 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 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: * 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
Frequently Asked Questions
Who can join the NCT05276791 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Barretts Esophagus With Dysplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05276791 currently recruiting?
Yes, NCT05276791 is actively recruiting participants. Visit ClinicalTrials.gov or contact St. Antonius Hospital to inquire about joining.
Where is the NCT05276791 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands, Eindhoven, Netherlands, Groningen, Netherlands, Nieuwegein, Netherlands and 2 additional locations.
Who is sponsoring the NCT05276791 clinical trial?
NCT05276791 is sponsored by St. Antonius Hospital. The trial plans to enroll 331 participants.