Neoplastic Barrett Esophagus: Endoscopic Piecemeal vs. En Bloc Resection

Launched by UNIVERSITÄTSKLINIKUM HAMBURG-EPPENDORF · Feb 2, 2018

Keywords

ClinConnect Summary

This clinical trial is looking at two different methods for removing abnormal tissue in patients with Barrett's esophagus, a condition that can lead to cancer. The study will compare two techniques called Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD) to see which one is more effective and safer for patients in the long run. Both methods will be used along with additional treatments to destroy any remaining abnormal cells.

To be eligible for the trial, participants should be adults aged between 65 and 74 who need treatment for Barrett's esophagus and have a specific type of tissue change that is less than 10 centimeters long. They must also be able to follow the treatment plan and provide signed consent. If someone has certain conditions, such as larger lesions or serious health issues, they may not qualify. Participants can expect regular check-ups and guidance throughout the treatment process to monitor their health and the effectiveness of the methods being tested.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • patients to be treated for Barrett's esophagus by mucosal resection and following ablative therapy
• • Barrett's mucosal extension up to 10 cm maximum.
• • patient's ability for compliance to therapy
• • signed Informed Consent
• Exclusion Criteria:
• • any lesion questionable to be resectable by mucosectomy, e.g. bulky lesions ≥10 mm in endoscopy und endosonography, suspected deep submucosal infiltration, ulcers, suspected or by FNA confirmed lymph node infiltration
• • Barrett's esophagus \> 10 cm
• • lesions that would afford resection of more than 2/3rd of esophagal circumference
• • two or more single Barrett's lesions with bulky HGIN or early cancer histology, not to be resectable in one half of esophageal circumference
• • planned circumferencial resections
• • very serious general illness and metastatic carcinoma
• • coagulation disorder or anticoagulants that make biopsies and resections impossible
• • American Society of Anesthesiologists (ASA) status \> III
• • pregnancy and lactation
• • remainders or recurrences after therapeutic history of Barrett's espohagus