esophageal adenocarcinoma, barrett neoplasia, barrett cancer esophageal cancer, barrett
Conditions
Interventions
Instead of immediate non-endoscopic treatment after R1 ER of a T1 EAC, all participants undergo baseline restaging with gastroscopy, combined with endoscopic ultrasound (EUS) and (PET-)CT-scans when h
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:R1/Rx* for esophageal adenocarcinoma in lateral resection margins after en-bloc resection, ORR1/Rx* for esophageal adenocarcinoma in vertical resection margins after en-bloc or piecemeal resectionSigned informed consent.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:Adenocarcinoma not originating from Barrett esophagus.Barrett esophagus is defined as presence of =1cm columnar epithelium in the distal esophagus during endoscopy, and histological presence of intestinal metaplasia Previous non-endoscopic treatment or R1/Rx endoscopic resection for esophageal neoplasiaSynchronous esophageal squamous cell carcinomaPatients unfit to undergo a follow-up endoscopy 6-8 weeks after endoscopic resectionPatients with refractory post-resection stricture in whom the resection scar cannot be assessedR2 resection with macroscopic residual tumor after or during endoscopic resectionPatients unable to give signed informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Residual intra-esophageal cancer at baseline restagingLocal intra-esophageal cancer recurrence <12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Local intra-esophageal high-grade dysplasia or cancer recurrence <5 yearsNeed for additional non-endoscopic treatment5-year disease-specific mortality/survival5-year overall survivalLymph node and/or distant metastases Health-related Quality of Life | — |
Countries
Australia, Belgium, Canada, Germany, Netherlands, Poland, Switzerland, United Kingdom
Contacts
Public ContactV Bos
Universitair Medisch Centrum Utrecht
Outcome results
None listed