Dysplasia in Barrett's esophagus precancerous esophageal mucosa
Conditions
Interventions
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent. 2. Age equal to or above 18 years (adult). 3. Minimum (residual) Barrett*s length of 2 cm and a maximum length of 5 cm (C0-5M2-5 according to the Prague classification) 4. Scheduled Barrett*s ablation for: a. Histologically proven intestinal metaplasia with either high- or low-grade dysplasia in the absence of any visible lesion, b. Residual Barrett*s mucosa after complete endoscopic resection (for visible lesions containing HGD or EAC.) (EMR
Exclusion criteria
Exclusion criteria: 1. Inability to give informed consent. 2. Age less than 18 years of age. 3. Presence of a visible lesion suspicious of early esophageal cancer or has a high chance of harboring cancer, or biopsy proven cancer. 4. In case of previous EMR: EMR specimen showing deep submucosal invasion (> 500µm), poorly to undifferentiated cancer (G3 or G4), lymphovascular invasion, or positive vertical margins. 5. In case of previous EMR: > 50% circumference. 6. Any prior endoscopic ablation treatment or dilation for esophageal stenosis. 7. Significant esophageal stenosis, preventing the passage of the therapeutic endoscope. 8. Evidence of portal hypertension, esophageal varices, etc. 9. An interval 6 months after the last high resolution endoscopy with biopsies containing low or high grade dysplasia. 11. Unable to undergo endoscopic procedure using sedation analgesics. 12. Anti-coagulant therapy (apart from monotherapy aspirin) that cannot be discontinued prior to the procedure, OR uncorrectable hemostatic disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate the safety of EndoRotor® ablation with regard to bleeding, perforation, and post-resection stenosis. 2. To evaluate the feasibility of EndoRotor® for the ablation of Barrett*s mucosa: The percentage of endoscopically visible surface regression of Barrett*s epithelium after 3 months post EndoRotor® treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate patient discomfort (recorded using the Numeric Rating Scale * grade 1-10), dysphagia-score (recorded using the Ogilvie score), and a variety of other symptoms (recorded using a 7 point Likert scale in a short 30 *day diary post procedure). 2. To assess the total time to resect tissue. 3. To evaluate the ease of performing the EndoRotor® procedure. | — |
Countries
The Netherlands
Outcome results
None listed