EMR Versus ESD for Barrett's Neoplasia

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Mar 9, 2022

Keywords

ClinConnect Summary

This clinical trial is comparing two methods for removing abnormal tissue in the esophagus that occurs in a condition called Barrett's esophagus. Barrett's esophagus can lead to serious problems, including cancer. The two techniques being studied are endoscopic mucosal resection (EMR), which is a widely used and straightforward method, and endoscopic submucosal dissection (ESD), which is more complex but may offer better results. Researchers want to see which method is more effective in ensuring that patients do not have any remaining or returning abnormal tissue after treatment.

To participate in this trial, individuals must be at least 18 years old and have a single visible lesion in Barrett's esophagus, with no signs that it has invaded deeper layers of the esophagus. Those who have had certain previous surgeries or treatments, or have multiple lesions, are not eligible. Participants will be randomly assigned to receive either EMR or ESD, and they will be monitored for 12 months after the procedure to check for any signs of remaining or returning abnormalities. This trial aims to help find the best way to treat Barrett's esophagus and improve patient outcomes.

Gender

ALL

Eligibility criteria

• 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