Radiofrequency Ablation in Patients With Barrett's Esophagus (RABE)
National Registry for Radiofrequency Ablation in Patients With Barrett's Esophagus
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:Matthias Paireder, MD
- 電話番号:56210 +43 1 40400
- メール:matthias.paireder@meduniwien.ac.at
研究場所
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Vienna、オーストリア、1090
- 募集
- Medical University of Vienna
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コンタクト:
- Matthias Paireder, MD
- 電話番号:56210 0043140400
- メール:matthias.paireder@meduniwien.ac.at
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コンタクト:
- Sebastian F Schoppmann, MD
- 電話番号:56210 0043140400
- メール:sebastian.schoppmann@meduniwien.ac.at
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:コホート
- 時間の展望:見込みのある
コホートと介入
グループ/コホート |
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BE
Patients presenting Barrett's Esophagus as a complication of a gastroesophageal reflux disease.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
Number of patients treated with Radiofrequency Ablation for Barrett's Esophagus in Austria
時間枠:5 years
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5 years
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Elimination Rate of Barrett's Esophagus in the study population
時間枠:5 years
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5 years
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協力者と研究者
スポンサー
協力者
捜査官
- スタディディレクター:Sebastian F Schoppmann, MD、Medical University of Vienna
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
胃食道逆流症の臨床試験
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