Neoplastic Barrett Esophagus: Endoscopic Piecemeal vs. En Bloc Resection
Status unconfirmed · Not applicable
Conditions studied: Barrett Esophagus, Barrett Adenocarcinoma, Esophagus Neoplasm
In brief
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.
Key facts
- Study ID
- NCT03427346
- Run by
- Universitätsklinikum Hamburg-Eppendorf
- People needed
- 407
- Starts
- 2016-12-01
- Expected to finish
- 2025-10-01
- Last updated by the study team
- 2023-06-28
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Orlando Health — Orlando, Florida, United States (enrolling)
- University Medical Center Hamburg-Eppendorf — Hamburg, Germany (enrolling)
Full record on ClinicalTrials.gov
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