EMR Versus ESD for Barrett's Neoplasia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Antonius Hospital
About this 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.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
EMR
Other interventionEndoscopic mucosal resection, according to standard care
ESD
Other interventionEndoscopic submucosal dissection, according to standard care
Treatment groups
331 Participants
are divided into 2 treatment groupsGroup A: Endoscopic submucosal dissectionActive comparator 1 intervention
Group B: Endoscopic mucosal resectionActive comparator 1 intervention
Trial outcomes
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 monthsSecondary outcomes
1
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 months2
Procedure times
a skewed continuous variable that will be compared using the Mann-Whitney U test.
Time frame
12 months3
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 months4
The total number of ER endoscopies per patient
This number will be compared using Poison regression analysis.
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
St. Antonius Hospital
Lead sponsor
University Medical Center Groningen
Collaborator
Erasmus Medical Center
Collaborator
UMC Utrecht
Collaborator
Amsterdam University Medical Center
Collaborator
Catharina Ziekenhuis Eindhoven
Collaborator
Source ClinicalTrials.gov