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临床试验/NCT02793479
NCT02793479Unknown不适用

National Registry for Radiofrequency Ablation in Patients With Barrett's Esophagus

Matthias Paireder1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2017年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
Number of patients treated with Radiofrequency Ablation for Barrett's Esophagus in Austria

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a histological confirmed BE, who give their informed consent for participation in an anonymized registry.

排除标准

  • Patients, who do not give informed consent.

结局指标

主要结局

Number of patients treated with Radiofrequency Ablation for Barrett's Esophagus in Austria

时间窗: 5 years

Elimination Rate of Barrett's Esophagus in the study population

时间窗: 5 years

次要结局

未报告次要终点

研究者

发起方
Matthias Paireder
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Matthias Paireder

Medical Doctor

Austrian Society Of Surgical Oncology

研究点 (1)

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