Status:
UNKNOWN
Neoplastic Barrett Esophagus: Endoscopic Piecemeal vs. En Bloc Resection
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Conditions:
Barrett Esophagus
Barrett Adenocarcinoma
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
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.
Detailed Description
For Barrett's Esophagus neoplasia of at least LGIN up to early adenocarcinoma, the aim is to debulk or completely treat polypoid dysplastic or malignant lesions in Barrett's esophagus. The Endoscopic ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
407 Patients enrolled
Trial Details
Trial ID
NCT03427346
Start Date
December 1 2016
End Date
October 1 2025
Last Update
June 28 2023
Active Locations (2)
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1
Orlando Health
Orlando, Florida, United States, 32806
2
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20246