EMR Versus ESD for Barrett's Neoplasia

NCT05276791 | Not Yet Recruiting

• 1 other identifier: 001
• Study Type: interventional
• Target: 331
• Locations: 0 countries
• Sites: N/A

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 a single visible lesion with absence of signs of submucosal invasion on endoscopy, after evaluation by the adjudication committee.

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• University Medical Center Groningen: collaborator
• Amsterdam UMC, location VUmc: collaborator
• Erasmus Medical Center: collaborator
• UMC Utrecht: collaborator
• Catharina Ziekenhuis Eindhoven: collaborator
• St. Antonius Hospital: collaborator

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: December 1, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share