Title
APE-Study: Ablation of Barrett's Mucosa vs. Surveillance Without Ablation in Patients Cured From Barrett's Cancer Combined With Randomization of Esomeprazole vs. Placebo for Symptomatic Reflux Control After Successful Barrett's Ablation
APE-Study: Tumor-free Survival After Ablation of Barrett's Mucosa Plus Esomeprazole vs. 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
Phase
N/ALead Sponsor
HSK WiesbadenStudy Type
InterventionalStatus
TerminatedIndication/Condition
Barrett's EsophagusIntervention/Treatment
esomeprazole ...Study Participants
68This 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.
concomitant esomeprazole treatment
comparison of recurrence-free survival
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