Ignite Creation Date:
2024-05-05 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00546065
Status:
TERMINATED
Last Update Posted:
2011-11-29
First Post:
2007-10-16
Brief Title:
APE-Study Ablation of Barretts Mucosa vs Surveillance Without Ablation in Patients Cured From Barretts Cancer Combined With Randomization of Esomeprazole vs Placebo for Symptomatic Reflux Control After Successful Barretts Ablation
Sponsor:
HSK Wiesbaden
Organization:
HSK Wiesbaden
Study Overview
Official Title:
APE-Study Tumor-free Survival After Ablation of Barretts Mucosa Plus Esomeprazole vs Surveillance Without Ablation in Patients Cured From Barretts Cancer Combined With Randomization of Esomeprazole vs Placebo for Symptomatic Reflux Control After Successful Ablation of Barretts Mucosa
Status:
TERMINATED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Intermediate results have shown a significant difference in the outcome of ablation and non-ablation patients Therefore the study was stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APE
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 Barretts mucosa plus esomeprazole versus surveillance without ablation in patients cured from Barretts cancer combined with randomization of esomeprazole vs placebo for symptomatic reflux control after successful ablation of Barretts mucosa
There are two hypotheses 1 Consecutive thermal ablation of metaplastic non-neoplastic long segments of Barretts esophagus 2cmplus 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 Barretts 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
There are two hypotheses 1 Consecutive thermal ablation of metaplastic non-neoplastic long segments of Barretts esophagus 2cmplus 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 Barretts 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None