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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Barrett's Esophagus

Intervention / Treatment
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* Drug: esomeprazole treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ablation of Barretts with concomitant esomeprazole therapy<br>comparison of recurrence-free survival | Drug: esomeprazole treatment<br>* concomitant esomeprazole treatment<br>|
| No Intervention: non ablation<br>non ablation only surveillance | Drug: esomeprazole treatment<br>* concomitant esomeprazole treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence-free survival | recurrence-free survival during 3 years of follow-up | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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