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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45236

Enrollment

Registered

2015-02-05

Start date

2015-09-14

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysplasia in Barrett's esophagus precancerous esophageal mucosa

Interventions

Radiofrequency ablation to eradicate Barrett's mucosa

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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 (

Exclusion criteria

Exclusion criteria: 1. Patients with a BE segment 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

Design outcomes

Primary

Measure	Time frame
Percentage of endoscopically visual surface regression of BE epithelium at 3 months, as scored by two independent endoscopists blinded to the treatment regimen.	—

Secondary

Measure	Time frame
1. Adverse events 2. Patient*s discomfort after RFA treatment 3. Procedure time	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)