Barrett's Esophagus
Conditions
Keywords
Barrett's esophagus, ablation, esomeprazole, Barrett's cancer, Ablation of Barrett's esophagus, Surveillance of Barrett's esophagus after endoscopic resection of Barrett's cancer, Recurrence of Barrett's cancer
Brief summary
This is a prospective, randomized, controlled, double-blinded, multi-center trial in a parallel-group design. Aim of the study is the evaluation of tumor-free survival after ablation (by APC, argon plasma coagulation) of Barrett's mucosa plus esomeprazole versus surveillance without ablation in patients cured from Barrett's cancer combined with randomization of esomeprazole vs placebo for symptomatic reflux control after successful ablation of Barrett's mucosa . There are two hypotheses: (1) Consecutive thermal ablation of metaplastic, non-neoplastic long segments of Barrett's esophagus (\>2cm)plus esomeprazole after successful endoscopic therapy of mucosal cancer by means of ER will decrease the incidence of secondary cancer (local recurrence and metachronous cancer) by a minimum of 50% compared to acid suppression alone without ablation within a 5-years follow-up (primary endpoint). (2) After successful ablation of Barrett's esophagus patients need ongoing acid suppression therapy for medical control of their underlying reflux disease (secondary aim of the study). Duration of the study: Patient recruitment period: 3 years. Follow-up period: 5 years. Total duration: 8 years. The study is already in the recruitment period.
Interventions
DRUGesomeprazole treatment
concomitant esomeprazole treatment
Sponsors
HSK Wiesbaden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Endoscopically and histologically complete remission of mucosal Barrett's cancer (endoscopic resection with or without thermal ablation of resection margins) * Initial length of Barrett's segment before cancer therapy \> 3 cm (initially long-segment Barrett's esophagus) * Barrett's length after endoscopic therapy of Barrett's cancer \> 2 cm * Informed consent of the patient
Exclusion criteria
* Attempted ablation therapy before the trial * Treatment duration of early Barrett's cancer \> 12 months * Duration between achievement of complete remission and attempted inclusion into the study \> 24 months * The Barrett's cancer treated has already been a secondary lesion of earlier Barrett's cancer * Inadequate healing of endoscopic resection (ER) ulcers * No residual Barrett's mucosa observed after pretreatment with ER * No PPI compliance * Relevant comorbidity (e.g., malignancy) * Pregnancy * Age below 18 years * Patient not able to understand study characteristics * No written informed consent available * Allergy against esomeprazole or intolerance of medication ingredients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| recurrence-free survival | 3 years | recurrence-free survival during 3 years of follow-up |
Countries
Germany
Outcome results
None listed