NL-OMON50590招募中不适用
Multicenter European prospective study on the efficacy and safety of the Focal C2 CryoBalloon Ablation System in patients with Barrett*s Esophagus-related neoplasia - Euro-Coldplay
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Indicated for ablation therapy of Barrett*s epithelium, determined by:
- •o Histopathologically-confirmed LGD or HGD in flat-type BE with four quadrant
- •biopsies of every 2cm of the BE segment in the last 6 months, or
- •o Residual flat BE (with or without dysplasia) after endoscopic resection of a
- •focal lesion (by means of EMR or ESD) of non-flat BE, at least 6 weeks prior to
- •enrolling the patient to this study. The histopathologic evaluation of the
- •resected specimen should indicate endoscopic treatment (i.e., no more than only
- •superficial submucosal invasion (<=T1sm1/<500 microns), absence of
- •lymphovascular invasion, not poorly differentiated, free deep (vertical)
- •resection margins).
- •NB: In case of performed endoscopic resection, the absence of residual cancer
- •in the remaining Barrett*s epithelium should be confirmed with random biopsies
- •(these biopsies might be taken during the same endoscopy, but a maximum
- •interval of 6 months is allowed between these biopsies).
- •2. Ablation naïve (no previous ablation therapy of the esophagus)
- •3. Prague Classification <=C2 / <=M5 (including BE tongues, excluding small BE
- •islands, in case of endoscopic resection the Prague Classification AFTER
- •endoscopic resection)
- •4. Older than 18 years of age at time of consent
- •5. Operable per institution*s standards
- •6. Informed consent
排除标准
- •1. Esophageal stenosis preventing advancement of a therapeutic endoscope
- •2. Prior endoscopic resection (EMR or ESD) >2cm in length AND/OR >50% of the
- •esophageal circumference
- •3. Prior distal oesophagectomy
- •4. Active oesophagitis grade B or higher (patients can be included after
- •appropriate treatment of reflux oesophagitis)
- •5. History of oesophageal varices
- •6. Achalasia
- •7. Severe medical comorbidities precluding endoscopy
- •8. Uncontrolled coagulopathy
- •9. Pregnant or planning to become pregnant during period of study participation
- •10. Life expectancy <=2 years, as judged by the site investigator
研究者
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