Self-sizing Radiofrequency ablation balloon for eradication of Barrett's esophagus: a randomized trial comparing two different treatment regimens

Phase 2

Completed

• Conditions: Dysplasia in Barrett's esophagus; precancerous esophageal mucosa; 10017990

• Registration Number: NL-OMON45236
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

1. Patients aged 18-85 years, with biopsy proven LGD, HGD or EC in a BE after local expert pathology review.
2. Scheduled circumferential ablation for BE with flat LGD, HGD, or for BE after prior endoscopic resection (ER) for lesions containing HGD or EC (<2 cm and <50% of the circumference).
3. Pretreatment biopsies and/or ER specimens reviewed by a local expert pathologist.
4. Written informed consent

Exclusion Criteria

1. Patients with a BE segment < 2cm or >15 cm prior to ER.
2. Any prior endoscopic ablation treatment.
3. Significant esophageal stenosis prior to initial treatment, preventing passage of a therapeutic endoscope OR any prior endoscopic dilatation for esophageal stenosis.
4. Presence of esophageal varices.
5. Anti-coagulant therapy (apart from aspirin or NSAID) that cannot be discontinued prior to ER or RFA, OR uncorrectable hemostatic disorders.
6. In case of prior ER: patients with ER of multiple lesions in a single ER session are not eligible, if one of the resections measures more than the aforementioned size criteria, OR if resections of different lesions are not separated by a free circumferential segment of at least 1 cm.
7. In case of prior ER: a specimen showing carcinoma with positive vertical resection margins, deep submucosal invasion (>T1sm1), poorly or undifferentiated cancer (G3 or G4), or lymphatic/vascular invasion.
8. In case of prior ER: invasive cancer in any of the biopsies obtained at high-resolution endoscopy after ER.
9. An interval >6 months between the last high-resolution endoscopy with biopsies and RFA.
10. An interval < 6 weeks between ER and RFA.
11. Patients unable to give informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Percentage of endoscopically visual surface regression of BE epithelium at 3<br /><br>months, as scored by two independent endoscopists blinded to the treatment<br /><br>regimen.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Adverse events<br /><br>2. Patient*s discomfort after RFA treatment<br /><br>3. Procedure time</p><br>