EMR Versus ESD for Barrett's Neoplasia

N/ANot Yet RecruitingNCT05276791

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)331 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

331

Conditions

Barretts Esophagus With Dysplasia Barrett Adenocarcinoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Primary endpoint is the proportion of patients with no evidence of residual or local recurrent neoplasia during 12 months follow-up after baseline.

Time frame: 12 months

Secondary Outcomes

Incidence of complications

. Complications will be assessed on patient level (yes/no) and chi-square test will be used to compare the outcomes between the study arms. In the case \> 25% of patients have multiple complications, assessment will be performed on complication level (n per patient) using Poisson-regression analysis.

Time frame: 12 months

Procedure times

a skewed continuous variable that will be compared using the Mann-Whitney U test.

Time frame: 12 months

Proportion of patients with endoscopically radical resection

assessed during the ER endoscopy, a proportion that will be compared using the chi2 test or Fisher's exact if the number of patients in a single category is \<5.

Time frame: 12 months

The total number of ER endoscopies per patient

This number will be compared using Poison regression analysis.

Time frame: 12 months

The proportion of patients that shows neoplastic progression

This will be compared with a chi2 test or Fisher's exact if the number of patients in a single category is \<5, and this analyses will be stratified for moment of detection (i.e. at baseline or later during the study duration).

Time frame: 12 months

Cost-effectiveness

Cost-effectiveness will be calculated by efficacy of both procedures (absence of residual or recurrent disease) divided by total costs in Euro associated with the procedures

Time frame: 12 months

Additional histopathologic evaluation may be performed to evaluate potential differences between the two techniques.

Interobserver agreement between the two techniques will be evaluated with Cohen's kappa, as well as a subjective score on ease of assessment on a NRS score ranging from 0-10.

Time frame: 12 months

EMR Versus ESD for Barrett's Neoplasia

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes