Barrett's EsophagusRABENCT02793479
Radiofrequency Ablation in Patients With Barrett's Esophagus
An observational study of Barrett's Esophagus and Radiofrequency Ablation, run by Matthias Paireder at 1 site in Austria.
Trial summary
The aim of this study is to establish a nationwide registry to collect data regarding the treatment of Barrett's Esophagus (BE) with radiofrequency ablation. The objective of this registry is to increase the number of data and therefore obtain a raise of quality assurance and improve outcome and patient security. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Barrett's Esophagus, Radiofrequency Ablation, Gastroesophageal Reflux Disease
- How many people
- 500 participants
- Where
- 1 siteAustria
- Study dates
- 1 Mar 2017to Dec 2021
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Each center should define a system for identification and eligibility screening of patients.
Who may be able to join
- Patients with a histological confirmed BE, who give their informed consent for participation in an anonymized registry.
Who cannot join
- Patients, who do not give informed consent.
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Matthias Paireder, MD, 0043140400 ext. 56210, matthias.paireder@meduniwien.ac.at
Sebastian F Schoppmann, MD, 0043140400 ext. 56210, sebastian.schoppmann@meduniwien.ac.at
About this study
Official title: National Registry for Radiofrequency Ablation in Patients With Barrett's Esophagus
The aim of this study is to establish a nationwide registry to collect data regarding the treatment of Barrett's Esophagus (BE) with radiofrequency ablation. The objective of this registry is to increase the number of data and therefore obtain a raise of quality assurance and improve outcome and patient security. Furthermore to provide participating physicians information and experience for treatment details in the therapy of BE.
Read the detailed description
For treatment of Barrett's Esophagus (BE), a condition considered as a complication of the gastroesophageal reflux disease (GERD), radiofrequency ablation (RFA) was introduced as a new method over 10 years ago. This method is already established in treating low- and high-grade dysplastic BE, but there is also a recommendation in therapy of non-dysplastic Barrett's esophagus (NDBE), if patients provide a increased cancer risk profile, such as long history of GERD (over 10 years), large hiatal hernia (over 3cm), esophagitis, history of BE with dysplasia or positive family history for gastrointestinal cancer.
In Austria 1 - 3% of the population is estimated to develop BE. The treatment numbers in each specialized centers therefore is low. To guarantee a better and more potent data analysis, the establishment of a nationwide registry is crucial. Furthermore this is essential to raise quality assurance and improve outcome and patients will benefit eventually.
The aim is the participation of about 10 departments, which are all qualified centers and experts, who offer RFA as a treatment for BE. Thus data can be collected and interpreted more exact due to the increased number of treated patients. For the purpose of data collection a structured electronic form will be used. This will further improve treatment documentation and quality.
Documentation will be performed in participating local centers. High priority is patient safety and data de-personalization. Data administration and data input should be performed through qualified medical personal via an online documentation platform. Original patients charts are archived at each center and data de-personalization is guaranteed via consecutive numbering when submitted to the study center.
Therefore protection of privacy of participating patients can be assured.
The registry should contain basis data of the patient as well as specific treatment data.
- Patient data Personal identification number (PIN) Sex Age Place of residence - county
- GERD history Typical, atypical symptoms Leading symptom Since when symptomatically Since when proton-pump inhibitor (PPI) treatment, dose Fundoplication y/n, Type, Date
- Endoscopy Date of diagnosis - Date of endoscopy Endoscopic Classification (Prague) Histological Classification
- Treatment Data Catheter type: 360°, 90° Energy: 10/12 J/cm2 Ablation catheter 18, 22, 25, 28, 31mm Ablation from … to … ab ore, length Complications
- Follow Up Date Endoscopic Classification (Prague) Histological Classification Complete remission of intestinal metaplasia (CR-IM) Proton-pump inhibitor (PPI), Dose
Inclusion of 500 patients a study period of two years is planned. There will be a possible extension of the study period, if the registry is successful.
- Medical subject headings
- Barrett Esophagus, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BE | Patients presenting Barrett's Esophagus as a complication of a gastroesophageal reflux disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients treated with Radiofrequency Ablation for Barrett's Esophagus in Austria
Measured: 5 years
Elimination Rate of Barrett's Esophagus in the study population
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study start1 Mar 2017
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Matthias Paireder
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Sponsor-investigator, Matthias Paireder, Austrian Society Of Surgical Oncology
- Investigators
- Sebastian F Schoppmann, MD, Study director, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793479
- Sponsor's protocol ID
- AUT-RFA-Registry-01
- Acronym
- RABE
- Status last verified
- Jul 2019
- First submitted
- 1 Jun 2016
- Last updated
- 5 Jul 2019
- Results posted
- No
Publications
Chandrasoma P, Makarewicz K, Wickramasinghe K, Ma Y, Demeester T. A proposal for a new validated histological definition of the gastroesophageal junction. Hum Pathol. 2006 Jan;37(1):40-7. doi: 10.1016/j.humpath.2005.09.019. Epub 2005 Nov 28.
PubMed 16360414Fleischer DE, Odze R, Overholt BF, Carroll J, Chang KJ, Das A, Goldblum J, Miller D, Lightdale CJ, Peters J, Rothstein R, Sharma VK, Smith D, Velanovich V, Wolfsen H, Triadafilopoulos G. The case for endoscopic treatment of non-dysplastic and low-grade dysplastic Barrett's esophagus. Dig Dis Sci. 2010 Jul;55(7):1918-31. doi: 10.1007/s10620-010-1218-1. Epub 2010 Apr 20.
PubMed 20405211Fleischer DE, Overholt BF, Sharma VK, Reymunde A, Kimmey MB, Chuttani R, Chang KJ, Muthasamy R, Lightdale CJ, Santiago N, Pleskow DK, Dean PJ, Wang KK. Endoscopic radiofrequency ablation for Barrett's esophagus: 5-year outcomes from a prospective multicenter trial. Endoscopy. 2010 Oct;42(10):781-9. doi: 10.1055/s-0030-1255779. Epub 2010 Sep 20.
PubMed 20857372
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Registry for Radiofrequency Ablation in Patients With Barrett's Esophagus
- ClinicalTrials.gov ID
- NCT02793479
- Acronym / sponsor ID
- RABE / AUT-RFA-Registry-01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Matthias PairederUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 8 Jun 2016 (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.
The aim of this study is to establish a nationwide registry to collect data regarding the treatment of Barrett's Esophagus (BE) with radiofrequency ablation. The objective of this registry is to increase the number of data and therefore obtain a raise of quality assurance and improve outcome and patient security. Furthermore to provide participating physicians information and experience for treatment details in the therapy of BE.
Detailed description
For treatment of Barrett's Esophagus (BE), a condition considered as a complication of the gastroesophageal reflux disease (GERD), radiofrequency ablation (RFA) was introduced as a new method over 10 years ago. This method is already established in treating low- and high-grade dysplastic BE, but there is also a recommendation in therapy of non-dysplastic Barrett's esophagus (NDBE), if patients provide a increased cancer risk profile, such as long history of GERD (over 10 years), large hiatal hernia (over 3cm), esophagitis, history of BE with dysplasia or positive family history for gastrointestinal cancer.
In Austria 1 - 3% of the population is estimated to develop BE. The treatment numbers in each specialized centers therefore is low. To guarantee a better and more potent data analysis, the establishment of a nationwide registry is crucial. Furthermore this is essential to raise quality assurance and improve outcome and patients will benefit eventually.
The aim is the participation of about 10 departments, which are all qualified centers and experts, who offer RFA as a treatment for BE. Thus data can be collected and interpreted more exact due to the increased number of treated patients. For the purpose of data collection a structured electronic form will be used. This will further improve treatment documentation and quality.
Documentation will be performed in participating local centers. High priority is patient safety and data de-personalization. Data administration and data input should be performed through qualified medical personal via an online documentation platform. Original patients charts are archived at each center and data de-personalization is guaranteed via consecutive numbering when submitted to the study center.
Therefore protection of privacy of participating patients can be assured.
The registry should contain basis data of the patient as well as specific treatment data.
- Patient data Personal identification number (PIN) Sex Age Place of residence - county
- GERD history Typical, atypical symptoms Leading symptom Since when symptomatically Since when proton-pump inhibitor (PPI) treatment, dose Fundoplication y/n, Type, Date
- Endoscopy Date of diagnosis - Date of endoscopy Endoscopic Classification (Prague) Histological Classification
- Treatment Data Catheter type: 360°, 90° Energy: 10/12 J/cm2 Ablation catheter 18, 22, 25, 28, 31mm Ablation from … to … ab ore, length Complications
- Follow Up Date Endoscopic Classification (Prague) Histological Classification Complete remission of intestinal metaplasia (CR-IM) Proton-pump inhibitor (PPI), Dose
Inclusion of 500 patients a study period of two years is planned. There will be a possible extension of the study period, if the registry is successful.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BE | – | –Patients presenting Barrett's Esophagus as a complication of a gastroesophageal reflux disease. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Each center should define a system for identification and eligibility screening of patients.
Key inclusion criteria (1 listed)
- Patients with a histological confirmed BE, who give their informed consent for participation in an anonymized registry.
Key exclusion criteria (1 listed)
- Patients, who do not give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients treated with Radiofrequency Ablation for Barrett's Esophagus in Austria
Time frame: 5 years
Elimination Rate of Barrett's Esophagus in the study population
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Background: PubMed 16360414Chandrasoma P, Makarewicz K, Wickramasinghe K, Ma Y, Demeester T. A proposal for a new validated histological definition of the gastroesophageal junction. Hum Pathol. 2006 Jan;37(1):40-7. doi: 10.1016/j.humpath.2005.09.019. Epub 2005 Nov 28.
- Background: PubMed 20405211Fleischer DE, Odze R, Overholt BF, Carroll J, Chang KJ, Das A, Goldblum J, Miller D, Lightdale CJ, Peters J, Rothstein R, Sharma VK, Smith D, Velanovich V, Wolfsen H, Triadafilopoulos G. The case for endoscopic treatment of non-dysplastic and low-grade dysplastic Barrett's esophagus. Dig Dis Sci. 2010 Jul;55(7):1918-31. doi: 10.1007/s10620-010-1218-1. Epub 2010 Apr 20.
- Background: PubMed 20857372Fleischer DE, Overholt BF, Sharma VK, Reymunde A, Kimmey MB, Chuttani R, Chang KJ, Muthasamy R, Lightdale CJ, Santiago N, Pleskow DK, Dean PJ, Wang KK. Endoscopic radiofrequency ablation for Barrett's esophagus: 5-year outcomes from a prospective multicenter trial. Endoscopy. 2010 Oct;42(10):781-9. doi: 10.1055/s-0030-1255779. Epub 2010 Sep 20.
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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.
Sebastian F Schoppmann, MD study director
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett's Esophagus and Radiofrequency Ablation, run by Matthias Paireder at 1 site in Austria.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Jul 2019. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthias Paireder, MD (+43 1 40400 ext. 56210, matthias.paireder@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients treated with Radiofrequency Ablation for Barrett's Esophagus in Austria (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02793479, which also lists 3 linked publications.
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 5 Jul 2019; AzTrials last refreshed its copy on 7 Nov 2026.