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NCT Number: NCT05276791

EMR Versus ESD for Barrett's Neoplasia

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.

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Key information

Conditions

Barretts Esophagus With Dysplasia Barrett Adenocarcinoma Barrett Esophagus Digestive System Diseases Digestive System Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam University Medical Center, Amsterdam, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EMR

Other

Endoscopic mucosal resection, according to standard care

ESD

Other

Endoscopic submucosal dissection, according to standard care

Primary outcomes

  1. 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 outcomes

  1. Incidence of complications

    Time frame: 12 months

    . Complications will be assessed on patient level (yes/no) and chi-square test will be used to compare the outcomes between the study arms. In the case > 25% of patients have multiple complications, assessment will be performed on complication level (n per patient) using Poisson-regression analysis.

  2. Procedure times

    Time frame: 12 months

    a skewed continuous variable that will be compared using the Mann-Whitney U test.

  3. Proportion of patients with endoscopically radical resection

    Time frame: 12 months

    assessed during the ER endoscopy, a proportion that will be compared using the chi2 test or Fisher's exact if the number of patients in a single category is <5.

  4. The total number of ER endoscopies per patient

    Time frame: 12 months

    This number will be compared using Poison regression analysis.

  5. The proportion of patients that shows neoplastic progression

    Time frame: 12 months

    This will be compared with a chi2 test or Fisher's exact if the number of patients in a single category is <5, and this analyses will be stratified for moment of detection (i.e. at baseline or later during the study duration).

  6. Cost-effectiveness

    Time frame: 12 months

    Cost-effectiveness will be calculated by efficacy of both procedures (absence of residual or recurrent disease) divided by total costs in Euro associated with the procedures

  7. Additional histopathologic evaluation may be performed to evaluate potential differences between the two techniques.

    Time frame: 12 months

    Interobserver agreement between the two techniques will be evaluated with Cohen's kappa, as well as a subjective score on ease of assessment on a NRS score ranging from 0-10.

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Collaborators

  • Amsterdam University Medical Center
  • Catharina Ziekenhuis Eindhoven
  • Erasmus Medical Center
  • UMC Utrecht
  • University Medical Center Groningen

Registry information

Official study title

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

Acronym: REMOVE-RCT

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Mar 11, 2022
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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