An interventional study of EMR and ESD in Barretts Esophagus With Dysplasia, Barrett Adenocarcinoma and Esophageal Cancer, sponsored by St. Antonius Hospital. Recruiting at 6 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by St. Antonius Hospital · Not applicable, Interventional, and Treatment
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.
1,873 studies on the registry are indexed under Esophageal Neoplasms; 501 are open to participants now.
This study's planned enrollment of 331 is above the median of 58 across 1,347 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →St. Antonius Hospital is the lead sponsor of 97 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: ESD
Other: EMR
Endoscopic mucosal resection, according to standard care
Endoscopic submucosal dissection, according to standard care
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
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.
Time frame: 12 months
Procedure times
a skewed continuous variable that will be compared using the Mann-Whitney U test.
Time frame: 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.
Time frame: 12 months
The total number of ER endoscopies per patient
This number will be compared using Poison regression analysis.
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
St. Antonius Hospital