EndoRotor® Ablation of Barrett's Esophagus: Safety and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety of EndoRotor® ablation of Barrett's mucosa; Number of participants with treatment related adverse events, such as bleeding, perforation or post procedural stenosis
研究概览
简要总结
The aim of this study is to assess the safety and feasibility of the EndoRotor® for the ablation of Barrett's esophagus.
详细描述
Prospective pilot study, to be performed in 30 patients with Barrett's esophagus that have an indication for ablation treatment. These include patients with low grade dysplasia (LGD), high grade dysplasia (HGD) or residual Barrett's after a complete endoscopic resection of a lesion containing HGD or esophageal adenocarcinoma. Ablation treatment will be performed by the EndoRotor ablation device, followed by surveillance endoscopy at 3 months where the feasibility for ablation will be assessed. During the 3 months follow-up, all adverse events such as perforation, post-procedural bleeding, stricture, and pain will be registered.
The EndoRotor® System is in automated mechanical endoscopic mucosal resection system for use in the gastrointestinal tract. The EndoRotor suctions up the tissue and cuts it, automatically sending the tissue to a collection trap for histological evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Age equal to or above 18 years (adult).
- •Minimum (residual) Barrett's length of 2 cm and a maximum length of 5 cm (C0-5M2-5 according to the Prague classification)
- •Scheduled Barrett's ablation for:
- •Histologically proven intestinal metaplasia with either high- or low-grade dysplasia in the absence of any visible lesion,
- •Residual Barrett's mucosa after complete endoscopic resection (for visible lesions containing HGD or EAC.) (EMR <50% of the circumference)
- •Favorable anatomy (e.g. straight esophagus, no previous anti-reflux procedure) that allows performing endoscopic treatment with the EndoRotor®.
排除标准
- •Presence of a visible lesion suspicious of early esophageal cancer or has a high chance of harboring cancer, or biopsy proven cancer.
- •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.
- •In case of previous EMR: > 50% circumference.
- •Any prior endoscopic ablation treatment or dilation for esophageal stenosis.
- •Significant esophageal stenosis, preventing the passage of the therapeutic endoscope.
- •Evidence of portal hypertension, esophageal varices, etc.
- •An interval < 6 weeks between EMR and EndoRotor treatment.
- •An interval of > 6 months after the last high resolution endoscopy with biopsies containing low or high grade dysplasia.
- •Unable to undergo endoscopic procedure using sedation analgesics.
- •Anti-coagulant therapy (apart from monotherapy aspirin) that cannot be discontinued prior to the procedure, OR uncorrectable hemostatic disorders.
结局指标
主要结局
Safety of EndoRotor® ablation of Barrett's mucosa; Number of participants with treatment related adverse events, such as bleeding, perforation or post procedural stenosis
时间窗: 3 months
Participants will have follow-up visits after the procedure during which the occurence of adverse events will be assessed. Adverse events will be classified according to the severity and onset timing.
Feasibility of EndoRotor® for the ablation of Barrett's mucosa
时间窗: 3 months
The percentage of endoscopically visible surface regression of Barrett's epithelium after 3 months post EndoRotor® treatment
次要结局
- To assess the dysphagia-score (recorded using the Ogilvie score)(1 month)
- Total time to resect tissue(Procedure)
- Ease of performing the EndoRotor® procedure(Procedure)
- To assess the patient discomfort (recorded using the Numeric Rating Scale - grade 1-10)(1 month)
- To assess a variety of symptoms (recorded using a 7 point Likert scale)(1 month)