Improving practicality of radiofrequency ablation for eradication of Barrett's mucosa: A randomized trial comparing three different treatment regimens for circumferential ablation using the HALO360 System.

Recruiting

Conditions: Barrett's esophagus
Barrett's dysplasia
early Barrett's neoplasia
radiofrequency ablation
endoscopy
Intestinal metaplasia
intraepithelial neoplasia.

Registration Number: NL-OMON21516

Lead Sponsor: AMC Amsterdam

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

1. Scheduled HALO360 ablation for BE with flat low-grade dysplasia (LGD) or high-grade dysplasia (HGD) or for BE (with or without neoplasia) after prior endoscopic resection (ER) for lesions containing HGD or and early cancer;

2. Review of histopathology specimens by a local expert pathologist;

Exclusion Criteria

1. In case of prior ER: A specimen showing carcinoma with positive vertical resection margins, deep submucosal invasion (≥ T1sm2), poorly or undifferentiated cancer (G3 or G4), or lymphatic/vascular invasion;

2. Patients unable to give informed consent.

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 as scored by two endoscopists blinded to the treatment regimen by using endoscopic images of the Barrett's esophagus prior to and 3 months after the the first treatment session (e.g. 80% of the Barrett's epithelium in regression). And, by using standardized case record forms on which the size and aspect of the Barrett's esophagis prior to and after the first treatment session are registered.

Secondary Outcome Measures

Name	Time	Method
1. Duration of the procedure (registered on the case record form);<br /><br>2. Amount and type of sedative medication necessary (registered on the case record form);<br /><br>3. Number of introductions of the ablation device and endoscope (registered on the case record form);<br /><br>4. Complications (prospectively registered in the 3months interval after treatment using case record forms);<br /><br>5. Patient's discomfort after HALO360 treatment (using a standardized questionnaire).