The efficacy and safety of a new radiofrequency ablation device for the treatment of Barrett's esophagus: a pilot study

Completed

• Conditions: Barrett's esophagus with biopsy-proven low-grade dysplasia, high-grade dysplasia or early cancer; Digestive System; Barrett oesophagus

• Registration Number: ISRCTN38642364
• Lead Sponsor: GI solutions, a subsidiary of Covidien, Inc. (Formerly BARRX Medical, Inc.)

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30228886

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-12-08
• Study Start: 2017-06-23
• Last Update Posted: 22 October 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Age 18 to 85 years
2. BE segment between 2 and 10 cm at baseline, prior to any ER
3. Biopsy proven LGD, HGD or cancer confirmed by an expert pathologist
4. in case of prior ER for early cancer or visible lesions, the resection had to be limited to <2 cm in length and <50 % of the circumference
5 Written informed consent

Exclusion Criteria

1. Prior endoscopic ablation treatment
2. Significant esophageal stenosis preventing passage of a diagnostic endoscope or any prior endoscopic dilatation for esophageal stenosis
3. In case of prior ER: positive vertical resection margins, deep submucosal invasion (>T1sm1), poorly or undifferentiated cancer (G3-G4), or lymphatic/vascular invasion
4. In case of prior ER: no invasive cancer in any of the biopsies obtained from residual BE
5. An interval of > 6 months between the last high-resolution endoscopy with biopsies and the RFA treatment, or an interval < 6 weeks between ER and RFA
6. Contra-indications for RFA treatment (e.g. anti-coagulant therapy (apart from aspirin or NSAID) that could not be discontinued prior to RFA, esophageal varices)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of endoscopically visual surface regression of BE epithelium at 3 months. The percentage of endoscopically visible surface regression of BE will be independently scored by two endoscopists who reviewed the endoscopic images that were taken from every cm of the original BE segment immediately prior to the initial circumferential RFA procedure and during the first post-treatment endoscopy at 3 months. The primary outcome is defined as the mean percentage of BE surface regression of the two endoscopists. In case the BE surface regression percentage differs =30% between both endoscopists, a new score will be established during a consensus meeting.