RECRUITING

Neoplastic Barrett Esophagus: Endoscopic Piecemeal vs. En Bloc Resection

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Conditions

Barrett EsophagusBarrett AdenocarcinomaEsophagus NeoplasmESDEMRendoscopic resection techniqueablation of esophageal mucosa

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2016-12
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03427346

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.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * patients to be treated for Barrett's esophagus by mucosal resection and following ablative therapy
  2. * Barrett's mucosal extension up to 10 cm maximum.
  3. * patient's ability for compliance to therapy
  4. * signed Informed Consent
  1. * 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
  2. * Barrett's esophagus \> 10 cm
  3. * lesions that would afford resection of more than 2/3rd of esophagal circumference
  4. * two or more single Barrett's lesions with bulky HGIN or early cancer histology, not to be resectable in one half of esophageal circumference
  5. * planned circumferencial resections
  6. * very serious general illness and metastatic carcinoma
  7. * coagulation disorder or anticoagulants that make biopsies and resections impossible
  8. * American Society of Anesthesiologists (ASA) status \> III
  9. * pregnancy and lactation
  10. * remainders or recurrences after therapeutic history of Barrett's espohagus

Contacts and Locations

Study Contact

Thomas Rösch, Prof. Dr.
CONTACT
+ 49 40 7410
t.roesch@uke.de
Hanno Ehlken, Dr.
CONTACT
+ 49 40 7410
h.ehlken@uke.de

Principal Investigator

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

Study Locations (Sites)

Orlando Health
Orlando, Florida, 32806
United States

Collaborators and Investigators

Sponsor: Universitätsklinikum Hamburg-Eppendorf

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-12
Study Completion Date2025-10

Study Record Updates

Study Start Date2016-12
Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

  • Barrett Esophagus
  • ESD
  • EMR
  • Esophagus Neoplasm
  • endoscopic resection technique
  • ablation of esophageal mucosa

Additional Relevant MeSH Terms

  • Barrett Esophagus
  • Barrett Adenocarcinoma
  • Esophagus Neoplasm