NCT00546065

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: HSK Wiesbaden · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Barrett's Esophagus

Interventions

Type	Name	Description
DRUG	esomeprazole treatment	concomitant esomeprazole treatment

Timeline

• Start date: 2006-08-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2007-10-18
• Last updated: 2011-11-29

Locations

1 site across 1 country: Germany