EMR Versus ESD for Barrett's Neoplasia

Not Applicable

Not yet recruiting

• Conditions: Barretts Esophagus With Dysplasia; Barrett Adenocarcinoma; Esophageal Cancer
• Interventions: Other: ESD; Other: EMR

• Registration Number: NCT05276791
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-01
• Study First Submitted QC: 2022-03-09
• Study First Posted: 2022-03-11
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-20
• Last Update Posted: 2022-07-21
• Study Start: 2022-12-01
• Primary Completion: 2025-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 331

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endoscopic submucosal dissection	ESD	-
Endoscopic mucosal resection	EMR	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Cost-effectiveness	12 months	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
Additional histopathologic evaluation may be performed to evaluate potential differences between the two techniques.	12 months	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.
Incidence of complications	12 months	. 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.
Procedure times	12 months	a skewed continuous variable that will be compared using the Mann-Whitney U test.
Proportion of patients with endoscopically radical resection	12 months	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.
The total number of ER endoscopies per patient	12 months	This number will be compared using Poison regression analysis.
The proportion of patients that shows neoplastic progression	12 months	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).