Self-sizing Radiofrequency ablation balloon for eradication of Barrett's esophagus: a randomized trial comparing two different treatment regimens - Self-sizing RFA balloon for Barrett's :RCT two regimens

Academisch Medisch Centrum0 个研究点目标入组 80 人开始时间: 待定最近更新: 2024年4月23日

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•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

•1. Patients with a BE segment < 2cm or >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.

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