- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02793479
Radiofrequency Ablation in Patients With Barrett's Esophagus (RABE)
National Registry for Radiofrequency Ablation in Patients With Barrett's Esophagus
Aperçu de l'étude
Statut
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Vienna, L'Autriche, 1090
- Recrutement
- Medical University of Vienna
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Contact:
- Matthias Paireder, MD
- Numéro de téléphone: 56210 0043140400
- E-mail: matthias.paireder@meduniwien.ac.at
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Contact:
- Sebastian F Schoppmann, MD
- Numéro de téléphone: 56210 0043140400
- E-mail: sebastian.schoppmann@meduniwien.ac.at
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Patients with a histological confirmed BE, who give their informed consent for participation in an anonymized registry.
Exclusion Criteria:
- Patients, who do not give informed consent.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
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BE
Patients presenting Barrett's Esophagus as a complication of a gastroesophageal reflux disease.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Number of patients treated with Radiofrequency Ablation for Barrett's Esophagus in Austria
Délai: 5 years
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5 years
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Elimination Rate of Barrett's Esophagus in the study population
Délai: 5 years
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5 years
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Sebastian F Schoppmann, MD, Medical University of Vienna
Publications et liens utiles
Publications générales
- 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.
- Fleischer 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.
- Fleischer 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- AUT-RFA-Registry-01
Informations sur les médicaments et les dispositifs, documents d'étude
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produit fabriqué et exporté des États-Unis.
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