Barretts Esophagus With DysplasiaREMOVE-RCTNCT05276791
EMR Versus ESD for Barrett's Neoplasia
A study testing EMR and ESD in people with Barretts Esophagus With Dysplasia and Barrett Adenocarcinoma, run by St. Antonius Hospital at 6 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barretts Esophagus With Dysplasia, Barrett Adenocarcinoma, Esophageal Cancer
- What is being tested?
- EMR and ESD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- 6 sitesNetherlands
- Study dates
- 17 Jan 2023to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Netherlands6 sites, 6 recruiting
- Recruiting
Amsterdam University Medical Center
Amsterdam
prof. dr. J. Bergman, +31887560655, s.j.albert-4@umcutrecht.nl
- Recruiting
Catharina Ziekenhuis
Eindhoven
dr. W. Curvers, +31887560655, s.j.albert-4@umcutrecht.nl
- Recruiting
University Medical Center Groningen
Groningen
prof. dr. W. Nagengast, +31887560655, s.j.albert-4@umcutrecht.nl
- Recruiting
St. Antonius Ziekenhuis
Nieuwegein
prof. dr. B.L.A.M. Weusten, +31887560655, s.j.albert-4@umcutrecht.nl
- Recruiting
Erasmus Medical Center
Rotterdam
dr. A. Koch, +31887560655, s.j.albert-4@umcutrecht.nl
- Recruiting
University Medical Center Utrecht
Utrecht
prof. dr. B.L.A.M. Weusten, +31887560655, s.j.albert-4@umcutrecht.nl
About this study
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
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.
Read more
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.
- Being tested
- EMR, ESD
- Keywords
- Barrett's esophagus, Esophagheal adenocarcinom
- Medical subject headings
- Esophageal Neoplasms, Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMROther
Endoscopic mucosal resection, according to standard care
ESDOther
Endoscopic submucosal dissection, according to standard care
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic submucosal dissection | Active comparator | Not described Receives: Other: ESD |
| Endoscopic mucosal resection | Active comparator | Not described Receives: Other: EMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint is the proportion of patients with no evidence of residual or local recurrent neoplasia during 12 months follow-up after baseline.
Measured: 12 months
Secondary outcomes (7)
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.
Measured: 12 months
Procedure times
a skewed continuous variable that will be compared using the Mann-Whitney U test.
Measured: 12 months
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.
Measured: 12 months
The total number of ER endoscopies per patient
This number will be compared using Poison regression analysis.
Measured: 12 months
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).
Measured: 12 months
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
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start17 Jan 2023
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barretts Esophagus With DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized study
- Masking
- None (open label)
- Enrolment
- 331 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen, Erasmus Medical Center, UMC Utrecht, Amsterdam University Medical Center, Catharina Ziekenhuis Eindhoven
- Responsible party
- Principal investigator, Sanne van Munster, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276791
- Sponsor's protocol ID
- 001
- Acronym
- REMOVE-RCT
- Status last verified
- Jun 2026
- First submitted
- 1 Mar 2022
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05276791
- Acronym / sponsor ID
- REMOVE-RCT / 001
- Keywords
- Barrett's esophagus, Esophagheal adenocarcinom
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 331 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Collaborators
- University Medical Center Groningen, Erasmus Medical Center, UMC Utrecht, Amsterdam University Medical Center, Catharina Ziekenhuis Eindhoven
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized study
| Arm | Type | Receives |
|---|---|---|
| Endoscopic submucosal dissection | Active comparator | Other: ESD |
| Endoscopic mucosal resection | Active comparator | Other: EMR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMREndoscopic mucosal resection, according to standard care | Other | Endoscopic mucosal resection |
| ESDEndoscopic submucosal dissection, according to standard care | Other | Endoscopic submucosal dissection |
Primary outcome
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
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMR and ESD in people with Barretts Esophagus With Dysplasia and Barrett Adenocarcinoma, run by St. Antonius Hospital at 6 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.