Clinical trial NCT05276791: EMR Versus ESD for Barrett's Neoplasia
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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Barretts Esophagus With Dysplasia
Barrett Adenocarcinoma
Esophageal Cancer
Keywords: Barrett's esophagus
Esophagheal adenocarcinom
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: University Medical Center Groningen
name: Amsterdam UMC, location VUmc
name: Erasmus Medical Center
name: UMC Utrecht
name: Catharina Ziekenhuis Eindhoven
name: St. Antonius Hospital
First posted: 2022-03-11
Enrollment: 331
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized study
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Primary endpoint is the proportion of patients with no evidence of residual or local recurrent neoplasia during 12 months follow-up after baseline.
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of complications
timeFrame: 12 months
measure: Procedure times
timeFrame: 12 months
measure: Proportion of patients with endoscopically radical resection
timeFrame: 12 months
measure: The total number of ER endoscopies per patient
timeFrame: 12 months
measure: The proportion of patients that shows neoplastic progression
timeFrame: 12 months
measure: Cost-effectiveness
timeFrame: 12 months
measure: Additional histopathologic evaluation may be performed to evaluate potential differences between the two techniques.
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References: