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EMR Versus ESD for Barrett's Neoplasia (REMOVE-RCT)

Primary Purpose

Barretts Esophagus With Dysplasia, Barrett Adenocarcinoma, Esophageal Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EMR
ESD
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Barretts Esophagus With Dysplasia focused on measuring Barrett's esophagus, Esophagheal adenocarcinom

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 a single visible lesion with absence of signs of submucosal invasion on endoscopy, after evaluation by the adjudication committee.

Exclusion Criteria:

  • Patients with visible lesions with suspicion of submucosal invasion bases on assessment of the adjudication committee
  • History of esophageal surgery other than fundoplication
  • History of esophageal ablation therapy or endoscopic resection
  • Multiple visible lesions in the BE segment at baseline
  • Uncontrolled coagulopathy with INR >2.0, thrombocytopenia with platelet counts < 50,000
  • 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 in-structions, or follow-up guidelines
  • Life expectancy <2 years

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Endoscopic submucosal dissection

    Endoscopic mucosal resection

    Arm Description

    Outcomes

    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.

    Secondary Outcome Measures

    Incidence of complications
    . 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.
    Procedure times
    a skewed continuous variable that will be compared using the Mann-Whitney U test.
    Proportion of patients with endoscopically radical resection
    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.
    The total number of ER endoscopies per patient
    This number will be compared using Poison regression analysis.
    The proportion of patients that shows neoplastic progression
    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).
    Cost-effectiveness
    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
    Additional histopathologic evaluation may be performed to evaluate potential differences between the two techniques.
    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.

    Full Information

    First Posted
    March 1, 2022
    Last Updated
    July 20, 2022
    Sponsor
    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    Collaborators
    University Medical Center Groningen, Amsterdam UMC, location VUmc, Erasmus Medical Center, UMC Utrecht, Catharina Ziekenhuis Eindhoven, St. Antonius Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05276791
    Brief Title
    EMR Versus ESD for Barrett's Neoplasia
    Acronym
    REMOVE-RCT
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2022 (Anticipated)
    Primary Completion Date
    December 1, 2025 (Anticipated)
    Study Completion Date
    December 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    Collaborators
    University Medical Center Groningen, Amsterdam UMC, location VUmc, Erasmus Medical Center, UMC Utrecht, Catharina Ziekenhuis Eindhoven, St. Antonius Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Barretts Esophagus With Dysplasia, Barrett Adenocarcinoma, Esophageal Cancer
    Keywords
    Barrett's esophagus, Esophagheal adenocarcinom

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized study
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    331 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Endoscopic submucosal dissection
    Arm Type
    Active Comparator
    Arm Title
    Endoscopic mucosal resection
    Arm Type
    Active Comparator
    Intervention Type
    Other
    Intervention Name(s)
    EMR
    Intervention Description
    Endoscopic mucosal resection, according to standard care
    Intervention Type
    Other
    Intervention Name(s)
    ESD
    Intervention Description
    Endoscopic submucosal dissection, according to standard care
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    Incidence of complications
    Description
    . 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.
    Time Frame
    12 months
    Title
    Procedure times
    Description
    a skewed continuous variable that will be compared using the Mann-Whitney U test.
    Time Frame
    12 months
    Title
    Proportion of patients with endoscopically radical resection
    Description
    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.
    Time Frame
    12 months
    Title
    The total number of ER endoscopies per patient
    Description
    This number will be compared using Poison regression analysis.
    Time Frame
    12 months
    Title
    The proportion of patients that shows neoplastic progression
    Description
    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).
    Time Frame
    12 months
    Title
    Cost-effectiveness
    Description
    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
    Time Frame
    12 months
    Title
    Additional histopathologic evaluation may be performed to evaluate potential differences between the two techniques.
    Description
    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.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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 a single visible lesion with absence of signs of submucosal invasion on endoscopy, after evaluation by the adjudication committee. Exclusion Criteria: Patients with visible lesions with suspicion of submucosal invasion bases on assessment of the adjudication committee History of esophageal surgery other than fundoplication History of esophageal ablation therapy or endoscopic resection Multiple visible lesions in the BE segment at baseline Uncontrolled coagulopathy with INR >2.0, thrombocytopenia with platelet counts < 50,000 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 in-structions, or follow-up guidelines Life expectancy <2 years

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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