Barrett's esophagus
Conditions
Interventions
Endoscopic treatment of Barrett's esophagus by means of endoscopic resection (either endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD)), radiofrequency ablation (RFA) or a c
Sponsors
Lead site:
Academic Medical Center Amsterdam (AMC)
Collaborating centers:
• Sint Antonius Hospital Nieuwegein
• Catharina Hospital, Eindhoven
• University Medical Center, Utrecht
• Isala Clinics, Zwolle
• Erasmus Medical Center, Rotterdam
• Haga Hospital, Den Haag
• University Medical Center, Groningen
Eligibility
Inclusion criteria
Inclusion criteria: 1) Males or females, all ages 2) Presence of Barrett’s esophagus, with presence of intestinal metaplasia in histologic assessment. 3) Referred for work-up in a BEC from 1/1/2007 to the moment of data collection. 4) Scheduled for endoscopic eradication therapy of BE 5) No written or oral refusal to use subject’s data
Exclusion criteria
Exclusion criteria: 1) Objection against participation in this study, through an opt-out card or e-mail 2) Referral for surgery after the work-up endoscopy for advanced EAC 3) Presence of non-dysplastic BE without an indication for treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to determine the proportion of patients with successful eradication of BE after endoscopic therapy. The primary endpoint will be the proportion of patients with a successful complete eradication of Barrett’s neoplasia (CE-Neo) after the treatment phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include: • The durability of a complete eradication of neoplasia and BE during follow-up, with follow-up determined as the interval between the first negative control endoscopy and the last follow-up endoscopy. • Failure for sustained CE-IM during FU is defined as recurrent visible BE (c>1 according to current guidelines)(10), independent of histology. If the patient was defined as CE-IM after the treatment phase with still some small BE islands present, this patient will be considered as sustained CE-IM during FU. • Only the patients with CE-IM at the end of the treatment phase will be included in this analysis. • Failure for sustained CE-neo during FU is defined as recurrent visible BE (c>1 according to current guidelines)(10) with HGD or EAC in biopsies. • Only the patients with CE-neo at the end of the treatment phase will be included in this analysis. • The safety after endoscopic therapy for BE • The incidence of complications such as a perforation or a stenosis will be assessed. • Predictors for a poor outcome after treatment • Predictors for a recurrence during follow-up • The optimum follow-up intervals after a CE-IM will be established | — |
Contacts
Public ContactJ.J.G.H.M. Bergman
Academic Medical Center Bldg. C2-210, Meibergdreef
Outcome results
None listed