EMR Versus ESD for Barrett's Neoplasia

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.

Conditions

• Barretts Esophagus With Dysplasia
• Barrett Adenocarcinoma
• Esophageal Cancer

Interventions

OTHER

EMR

Endoscopic mucosal resection, according to standard care

OTHER

ESD

Endoscopic submucosal dissection, according to standard care

Sponsors & Collaborators

• University Medical Center Groningen

  collaborator OTHER

• Amsterdam UMC, location VUmc

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• UMC Utrecht

  collaborator OTHER

• Catharina Ziekenhuis Eindhoven

  collaborator OTHER

• St. Antonius Hospital

  collaborator OTHER

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

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-01

Primary Completion

2025-12-01

Completion

2026-12-01