EMR Versus ESD for Barrett's Neoplasia

NCT05276791 | Recruiting

• 1 other identifier: 001
• Study Type: interventional
• Target: 331
• Locations: 1 country
• Sites: 6

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.

Conditions

Barretts Esophagus With Dysplasia; Barrett Adenocarcinoma; Esophageal Cancer

Keywords

Barrett's esophagus; Esophagheal adenocarcinom

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Incidence of complications

  12 months

• Procedure times

  12 months

• Proportion of patients with endoscopically radical resection

  12 months

• The total number of ER endoscopies per patient

  12 months

• The proportion of patients that shows neoplastic progression

  12 months

Study Arms (2)

Endoscopic submucosal dissection

ACTIVE COMPARATOR

Other: ESD

Endoscopic mucosal resection

ACTIVE COMPARATOR

Other: EMR

Interventions

EMR OTHER

Endoscopic mucosal resection, according to standard care

Endoscopic mucosal resection

ESD OTHER

Endoscopic submucosal dissection, according to standard care

Endoscopic submucosal dissection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 at least one visible lesion ("target lesion") with absence of signs of submucosal invasion on endoscopy, after evaluation by the adjudication committee
• Multiple lesions are allowed as long as the lesions are considered eligible for endoscopic treatment. Only the target lesion is evaluated for the study
• Prior endoscopic resection is allowed

You may not qualify if:

• Patients with visible lesions with suspicion of submucosal invasion based on assessment of the adjudication committee
• History of esophageal surgery other than fundoplication
• History of esophageal ablation therapy
• In case of prior endoscopic resection, the target lesion located within 1 cm of the prior resection site
• Uncontrolled coagulopathy with INR \>2.0, thrombocytopenia with platelet counts \< 50,000
• Esophageal varix or varices
• 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 instructions, or follow-up guidelines
• Life expectancy \<2 years

Sponsors & Collaborators

• University Medical Center Groningen: collaborator
• Erasmus Medical Center: collaborator
• UMC Utrecht: collaborator
• Catharina Ziekenhuis Eindhoven: collaborator
• St. Antonius Hospital: lead
• Amsterdam University Medical Center: collaborator

Study Sites (6)

Amsterdam University Medical Center

Amsterdam, Netherlands

RECRUITING

Catharina Ziekenhuis

Eindhoven, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, Netherlands

RECRUITING

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

RECRUITING

Erasmus Medical Center

Rotterdam, Netherlands

RECRUITING

University Medical Center Utrecht

Utrecht, Netherlands

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Barrett Esophagus

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Precancerous Conditions

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (Bas Weusten)

Model Details: Randomized study

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 11, 2022
• Study Start: January 17, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (6)