Barretts Esophagus With Dysplasia, Barrett Adenocarcinoma, Esophageal Cancer
Conditions
Keywords
Barrett's esophagus, Esophagheal adenocarcinom
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.
Interventions
Sponsors
University Medical Center Groningen
Amsterdam UMC, location VUmc
Erasmus Medical Center
UMC Utrecht
Catharina Ziekenhuis Eindhoven
St. Antonius Hospital
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the proportion of patients with no evidence of residual or local recurrent neoplasia during 12 months follow-up after baseline. | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure times | 12 months | a skewed continuous variable that will be compared using the Mann-Whitney U test. |
| Proportion of patients with endoscopically radical resection | 12 months | 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 | 12 months | This number will be compared using Poison regression analysis. |
| Incidence of complications | 12 months | . 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. |
| Cost-effectiveness | 12 months | 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. | 12 months | 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. |
| The proportion of patients that shows neoplastic progression | 12 months | 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). |
Outcome results
None listed