Confocal Laser Endomicroscopy for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 10
- 主要终点
- Number of Barrett's Esophagus (BE) Participants With a Composite Outcome of "Optimally Treated"
研究概览
简要总结
This study focuses on demonstrating the value of probe-based Confocal Laser Endomicroscopy (pCLE) in guiding endoscopic therapeutic procedures in Barrett's Esophagus (BE).
It is a randomized controlled outcomes study including patients already treated for Barrett's Esophagus lesion(s) and undergoing high definition white light endoscopy follow up procedure, with or without pCLE (2 arms will be considered in this study). The procedures will be carried out per standards of practice with appropriately trained physicians.
详细描述
It is a randomized controlled outcomes study including patients already treated for Barrett's Esophagus lesion(s) and undergoing high definition white light endoscopy follow up procedure, with or without pCLE guided evaluation (2 arms will be considered in this study). The procedures will be carried out per standards of practice with appropriately trained physicians.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- •Patients with BE with Intestinal Metaplasia, Low Grade-IntraEpithelial Neoplasia/High Grade-IntraEpithelial Neoplasia as the original indication for ablative treatment.
- •Undergoing any type of endoscopic BE ablation treatment
- •<2cm of circumferential BE and <5 total islands of BE on prior to last ablation.
- •Age > 18 years
- •Ability to provide written, informed consent
排除标准
- •Participation in another clinical study
- •Circumferential BE
- •Complete eradication of BE documented by biopsies
- •Inability to obtain biopsies due to anticoagulation, varices, etc.
- •Allergy to fluorescein
- •Pregnancy
- •Renal insufficiency
结局指标
主要结局
Number of Barrett's Esophagus (BE) Participants With a Composite Outcome of "Optimally Treated"
时间窗: 3 month follow-up endoscopic procedure
Number of Barrett's Esophagus (BE) Participants with a Composite Outcome of "Optimally Treated", in each group defined as patients for whom all lesions are ablated when disease is present, or not ablated when disease is absent, or have complete ablation of all disease at the 3 month follow-up.
次要结局
未报告次要终点