RecruitingNot ApplicableNCT05276791

EMR Versus ESD for Barrett's Neoplasia

Endoscopic Mucosal Resection Versus Endoscopic subMucosal Dissection fOr Removal of Visible Lesions in Barrett's Esophagus With Early Neoplasia: a Randomized Controlled Trial


Sponsor

St. Antonius Hospital

Enrollment

331 participants

Start Date

Jan 17, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying EMR and ESD for people with barrett adenocarcinoma, barretts esophagus with dysplasia, and other related conditions. The study is currently recruiting participants at 6 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEREMR

Endoscopic mucosal resection, according to standard care

OTHERESD

Endoscopic submucosal dissection, according to standard care


Locations(6)

Amsterdam University Medical Center

Amsterdam, Netherlands

Catharina Ziekenhuis

Eindhoven, Netherlands

University Medical Center Groningen

Groningen, Netherlands

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Erasmus Medical Center

Rotterdam, Netherlands

University Medical Center Utrecht

Utrecht, Netherlands

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NCT05276791


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