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
About this trial
This is an interventional treatment trial for Barretts Esophagus With Dysplasia focused on measuring Barrett's esophagus, Esophagheal adenocarcinom
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
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
NCT ID
NCT05276791
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
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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EMR Versus ESD for Barrett's Neoplasia
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