Menu
Recruiting NCT05276791

EMR Versus ESD for Barrett's Neoplasia

No phase Interventional Barretts Esophagus With Dysplasia Barrett Adenocarcinoma Esophageal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EMR, ESD.
Who it may be relevant to
Registry conditions: Barretts Esophagus With Dysplasia, Barrett Adenocarcinoma, Esophageal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Endoscopic Mucosal Resection Versus Endoscopic subMucosal Dissection fOr Removal of Visible Lesions in Barrett's Esophagus With Early Neoplasia: a Randomized Controlled Trial

Overview

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.

Interventions

  • Other EMR
    Endoscopic mucosal resection, according to standard care
  • Other ESD
    Endoscopic submucosal dissection, according to standard care

Primary outcome measures

  • Primary endpoint is the proportion of patients with no evidence of residual or local recurrent neoplasia during 12 months follow-up after baseline. [Time frame: 12 months]
Secondary outcome measures (7)
  • Incidence of complications [Time frame: 12 months]
  • Procedure times [Time frame: 12 months]
  • Proportion of patients with endoscopically radical resection [Time frame: 12 months]
  • The total number of ER endoscopies per patient [Time frame: 12 months]
  • The proportion of patients that shows neoplastic progression [Time frame: 12 months]
  • Cost-effectiveness [Time frame: 12 months]
  • Additional histopathologic evaluation may be performed to evaluate potential differences between the two techniques. [Time frame: 12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Netherlands · 6 centers
  • Amsterdam University Medical Center — Amsterdam
  • Catharina Ziekenhuis — Eindhoven
  • University Medical Center Groningen — Groningen
  • St. Antonius Ziekenhuis — Nieuwegein
  • Erasmus Medical Center — Rotterdam
  • University Medical Center Utrecht — Utrecht

Identifiers

NCT: NCT05276791 · 001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗