EndoRotor ablation of Barrett's esophagus: Safety and Feasibility study - EndoRotor ablation of Barrett's esophagus: Safety and Feasibility study

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年2月28日

适应症

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•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 <50% of the circumference)
•5. Favorable anatomy (e.g. straight esophagus, no previous anti-reflux procedure) that allows performing endoscopic treatment with the EndoRotor®.

•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 weeks between EMR and EndoRotor treatment.
•10. An interval of > 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.

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