Barrett's esophagus, Barrett's neoplasia, Barrett's dysplasia, Radiofrequency ablation, Intestinal metaplasia
Conditions
Interventions
Circumferential radiofrequency ablation of Barrett's
esophagus with the Self-sizing RFA balloon.
Inspection of the Barrett’s segment and randomization
The esophagus is evaluated using white light hi
Sponsors
KU Gasthuisberg Leuven, Belgium
Eligibility
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 (<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
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 < 6 weeks between ER and RFA. 11. Patients unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: 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 | — |
Contacts
Public ContactJ.J.G.H.M. Bergman
AMC Departement of Gastroenterology C2-216
Outcome results
None listed