Barrett's EsophagusAPENCT00546065
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
A study testing esomeprazole treatment in people with Barrett's Esophagus, run by HSK Wiesbaden at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett's Esophagus
- What is being tested?
- esomeprazole treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2006to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read more
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
- Being tested
- esomeprazole treatment
- 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
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esomeprazole treatmentDrug
concomitant esomeprazole treatment
| Study group | Role | What they receive |
|---|---|---|
| ablation of Barretts with concomitant esomeprazole therapy | Other | comparison of recurrence-free survival Receives: Drug: esomeprazole treatment |
| non ablation | No intervention | non ablation only surveillance Receives: Drug: esomeprazole treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence-free survival
recurrence-free survival during 3 years of follow-up
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2007 (estimated)
- Study startAug 2006
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: Intermediate results have shown a significant difference in the outcome of ablation and non-ablation patients. Therefore, the study was stopped.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- HSK Wiesbaden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Ell, MD PhD, Principal investigator, HSK Wiesbaden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546065
- Sponsor's protocol ID
- D9612L00088
- Acronym
- APE
- Status last verified
- Nov 2011
- First submitted
- 16 Oct 2007
- Last updated
- 29 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00546065
- Acronym / sponsor ID
- APE / D9612L00088
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Intermediate results have shown a significant difference in the outcome of ablation and non-ablation patients. Therefore, the study was stopped.
- Enrolment
- 68 participants (actual)
- Lead sponsor
- HSK WiesbadenUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 18 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ablation of Barretts with concomitant esomeprazole therapy | Other | Drug: esomeprazole treatmentcomparison of recurrence-free survival |
| non ablation | No intervention | Drug: esomeprazole treatmentnon ablation only surveillance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| esomeprazole treatmentconcomitant esomeprazole treatment | Drug | ablation of Barretts with concomitant esomeprazole therapy, non ablation |
Primary outcome
recurrence-free survival
Time frame: 3 years
recurrence-free survival during 3 years of follow-up
Results and safety
The study was stopped early (reason given: Intermediate results have shown a significant difference in the outcome of ablation and non-ablation patients. Therefore, the study was stopped.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Ell, MD PhD principal investigator
HSK Wiesbaden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing esomeprazole treatment in people with Barrett's Esophagus, run by HSK Wiesbaden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Intermediate results have shown a significant difference in the outcome of ablation and non-ablation patients. Therefore, the study was stopped.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence-free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2011.