Barretts Esophagus With DysplasiaBarrett AdenocarcinomaEsophageal Cancer
Investigational drug(s) / intervention(s)
EMRESD
EMR: Endoscopic mucosal resection, according to standard care
ESD: Endoscopic submucosal dissection, according to standard care
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Primary endpoint is the proportion of patients with no evidence of residual or local recurrent neoplasia during 12 months follow-up after baseline. — 12 months
Trial sites (6)
Facility
City
Region
Status
Amsterdam University Medical Center
Amsterdam
Netherlands
Recruiting
Catharina Ziekenhuis
Eindhoven
Netherlands
Recruiting
University Medical Center Groningen
Groningen
Netherlands
Recruiting
St. Antonius Ziekenhuis
Nieuwegein
Netherlands
Recruiting
Erasmus Medical Center
Rotterdam
Netherlands
Recruiting
University Medical Center Utrecht
Utrecht
Netherlands
Recruiting
More St. Antonius Hospital trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.