Barrett's esophagus early cancer
Conditions
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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. - Review of histopathology specimens by a local expert pathologist - Written informed consent
Exclusion criteria
Exclusion criteria: - In case of prior Endoscopic resection: a specimen showing carcinoma with positive vertical resection margins, deep submucosal invasion (* T1sm2), poorly or undifferentiated cancer (G3 or G4), or lymphatic/vascular invasion. - Patients unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of endoscopically visual surface regression of BE epithelium at 3 months as scored by two endoscopists blinded to the treatment regimen | — |
Secondary
| Measure | Time frame |
|---|---|
| - Duration of the procedure - Amount and type of sedative medication necessary - Number of introductions of the ablation device and endoscope - Complications - Patient*s discomfort (VAS-score) after HALO360 treatment | — |
Countries
Netherlands
Outcome results
None listed