Back to resultsAPE-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)
Primary Purpose
Barrett's Esophagus
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
esomeprazole treatment
Sponsored by
About this trial
This is an interventional prevention trial for Barrett's Esophagus focused on measuring 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
Eligibility Criteria
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
Sites / Locations
- HSK Wiesbaden
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
ablation of Barretts with concomitant esomeprazole therapy
non ablation
Arm Description
comparison of recurrence-free survival
non ablation only surveillance
Outcomes
Primary Outcome Measures
recurrence-free survival
recurrence-free survival during 3 years of follow-up
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00546065
Brief 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
Acronym
APE
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Terminated
Why Stopped
Intermediate results have shown a significant difference in the outcome of ablation and non-ablation patients. Therefore, the study was stopped.
Study Start Date
August 2006 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HSK Wiesbaden
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett's Esophagus
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ablation of Barretts with concomitant esomeprazole therapy
Arm Type
Other
Arm Description
comparison of recurrence-free survival
Arm Title
non ablation
Arm Type
No Intervention
Arm Description
non ablation only surveillance
Intervention Type
Drug
Intervention Name(s)
esomeprazole treatment
Intervention Description
concomitant esomeprazole treatment
Primary Outcome Measure Information:
Title
recurrence-free survival
Description
recurrence-free survival during 3 years of follow-up
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Ell, MD PhD
Organizational Affiliation
HSK Wiesbaden
Official's Role
Principal Investigator
Facility Information:
Facility Name
HSK Wiesbaden
City
Wiesbaden
State/Province
Hesse
ZIP/Postal Code
65199
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
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
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