EMR Versus ESD for Barrett's Neoplasia

Esophageal Cancer Clinical Trial

— REMOVE-RCT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05276791
• Other study ID #: 001
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 1, 2026

Study information

• Verified date: July 2022
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 331
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barrett Adenocarcinoma
• Barrett Esophagus
• Barretts Esophagus With Dysplasia
• Esophageal Cancer

Intervention

Other:
• EMR
Endoscopic mucosal resection, according to standard care
• ESD
Endoscopic submucosal dissection, according to standard care

Locations

Country	Name	City	State
n/a

Sponsors (7)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	12 months
Secondary	Procedure times	a skewed continuous variable that will be compared using the Mann-Whitney U test.	12 months
Secondary	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.	12 months
Secondary	The total number of ER endoscopies per patient	This number will be compared using Poison regression analysis.	12 months
Secondary	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).	12 months
Secondary	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	12 months
Secondary	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.	12 months