Radiofrequency Ablation in Patients With Barrett's Esophagus

• Conditions: Radiofrequency Ablation; Gastroesophageal Reflux Disease; Barrett's Esophagus

• Registration Number: NCT02793479
• Lead Sponsor: Matthias Paireder

Brief 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. 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.

1. Patient data Personal identification number (PIN) Sex Age Place of residence - county

2. GERD history Typical, atypical symptoms Leading symptom Since when symptomatically Since when proton-pump inhibitor (PPI) treatment, dose Fundoplication y/n, Type, Date

3. Endoscopy Date of diagnosis - Date of endoscopy Endoscopic Classification (Prague) Histological Classification

4. 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

5. 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 Timeline

• Study First Submitted: 2016-06-01
• Study First Submitted QC: 2016-06-07
• Study First Posted: 2016-06-08
• Study Start: 2017-03-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients treated with Radiofrequency Ablation for Barrett's Esophagus in Austria	5 years
Elimination Rate of Barrett's Esophagus in the study population	5 years

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria