K22.7 C15.5
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: EMR or ESD in the period from 01/01/2003 to 12/31/2020 with endoscopic visible suspicious Barrett´s lesion or a histologically confirmed Barrett´s associated HGIEN or an early Barrett's carcinoma
Exclusion criteria
Exclusion criteria: - age <18 years - squamous cell neoplasia - signs for tumor infiltration of the tunica muscularis in endoscopic ultrasound - Metastasis at the time of index intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| combined primary endpoint of 1. endoscopically complete resection of Barrett's neoplasia (carcinoma or HGIEN) with neoplasia-free resection margin vertical - R0, L0, V0 - and - 2. Neoplasia-free survival in the follow-up of 12 months, defined by excluding Barrett's carcinoma or HGIEN in endoscopic follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| - complication rate, defined as perforation requiring intervention (haemoclip, stent, surgery) or major bleeding (endoscopic intervention, blood transfusion) periinterventionally and within 30 days - Peri- or post-interventional minor bleeding within 30 days - Percentage of post-interventional strictures requiring further therapeutic interventions - Mortality within 30 days and 3 months - Recurrence-free survival in follow-up of at least 6, 12, 24, 36, 48 and 60 months - en bloc resection of Barrett's neoplasia - Percentage of required re-resection if the R0 resection is primarily absent - duration of the procedure | — |
Countries
Germany
Contacts
Klinikum Oldenburg AöR, Universitätsklinik für Innere Medizin - Gastroenterologie, Hepatologie, Stoffwechselmedizin, Nieren- und Hochdruckerkrankungen