Dysplasia in Barrett's precancerous esophageal mucosa
Conditions
Interventions
Radiofrequnecy ablation to eradicate barrett's mucosa
Sponsors
GI solutions, a subsidiary of Covidien, Inc. (Formerly BARRX Medical, Inc.)
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 confirmed after expert pathology review. 2. Scheduled circumferential ablation for BE with flat 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 10 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. An interval
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Percentage of endoscopically visual surface regression of BE epithelium at 3 months, as scored by two independent endoscopists. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Number of Adverse events: The number of patients who reported acute (periprocedural), early (48 hrs) complications. 2) Duration and acceptability of the ablation procedure: Time of first introduction of the endoscope, time of the first introduction of the Self-sizer balloon and the time of final removal of the Self-sizer balloon are recorded during the endoscopy. | — |
Countries
Netherlands
Outcome results
None listed