EMR Versus ESD for Barrett's Neoplasia (REMOVE-RCT)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status

Not yet enrolling

Conditions

Esophageal Cancer

Barretts Esophagus With Dysplasia

Barrett Adenocarcinoma

Treatments

Other: EMR

Other: ESD

Study type

Interventional

Funder types

Other

Identifiers

NCT05276791

001

Details and patient eligibility

About

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.

Enrollment

331 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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