Radiofrequency Ablation in Patients With Barrett's Esophagus

NCT ID: NCT02793479

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2021-12-31

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.

Conditions

Barrett's Esophagus; Radiofrequency Ablation; Gastroesophageal Reflux Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

BE

Patients presenting Barrett's Esophagus as a complication of a gastroesophageal reflux disease.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: collaborator

Matthias Paireder

OTHER

Sponsor Role: lead

Responsible Party

Matthias Paireder

Medical Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sebastian F Schoppmann, MD

Role: STUDY_DIRECTOR

Medical University of Vienna

Locations

Medical University of Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Matthias Paireder, MD

Role: CONTACT

matthias.paireder@meduniwien.ac.at

+43 1 40400 ext. 56210

Facility Contacts

Matthias Paireder, MD

Role: primary

matthias.paireder@meduniwien.ac.at

0043140400 ext. 56210

Sebastian F Schoppmann, MD

Role: backup

sebastian.schoppmann@meduniwien.ac.at

0043140400 ext. 56210

References

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.

Reference Type: BACKGROUND

PMID: 16360414 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20405211 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20857372 (View on PubMed)

Other Identifiers

AUT-RFA-Registry-01

Identifier Type: -

Identifier Source: org_study_id