Neoplastic Barrett Esophagus: Endoscopic Piecemeal vs. En Bloc Resection

Description

The study will compare EMR versus ESD technique (both combined with subsequent ablative therapy) of mucosal resection in Barrett's esophagus with regard to efficacy and risk in a long term setting.

Conditions

Barrett Esophagus, Barrett Adenocarcinoma, Esophagus Neoplasm

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Study Overview

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Study Details

Study overview

The study will compare EMR versus ESD technique (both combined with subsequent ablative therapy) of mucosal resection in Barrett's esophagus with regard to efficacy and risk in a long term setting.

Prospektiv-randomisierter Vergleich Von En-bloc- Versus Piecemeal-Resektion Von Barrett Neoplasien Des Ösophagus Neoplastic Barrett Esophagus: Endoscopic Piecemeal vs. En Bloc Resection

Neoplastic Barrett Esophagus: Endoscopic Piecemeal vs. En Bloc Resection

Condition
Barrett Esophagus
Intervention / Treatment

-

Contacts and Locations

Orlando

Orlando Health, Orlando, Florida, United States, 32806

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Universitätsklinikum Hamburg-Eppendorf,

Thomas Rösch, Prof. Dr., PRINCIPAL_INVESTIGATOR, Ph D, Director, Head of department

Study Record Dates

2025-10