NCT05276791Recruiting
EMR Versus ESD for Barrett's Neoplasia
Endoscopic Mucosal Resection Versus Endoscopic subMucosal Dissection fOr Removal of Visible Lesions in Barrett's Esophagus With Early Neoplasia: a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 29 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 331 (estimated)
- First submitted
- 1 Mar 2022
- Start date
- 17 Jan 2023
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- St. Antonius Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05276791
What you commit to
- Study type: Interventional
- Planned participants: 331
- From 17 Jan 2023 to the primary completion date, 1 Dec 2027
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- In case of prior endoscopic resection, the target lesion located within 1 cm of the prior resection site
Other illness
- History of esophageal surgery other than fundoplication
- History of esophageal ablation therapy
- 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
Lab values
- Uncontrolled coagulopathy with INR \>2.0, thrombocytopenia with platelet counts \< 50,000
Age
- Life expectancy \<2 years
Other
- Patients with visible lesions with suspicion of submucosal invasion based on assessment of the adjudication committee
- Esophageal varix or varices
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam University Medical Center Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Catharina Ziekenhuis Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Recruiting |
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| St. Antonius Ziekenhuis Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Recruiting |
| Erasmus Medical Center Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| University Medical Center Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.