Cap Assisted Upper Endoscopy Versus High Definition White Light Endoscopy and Narrow Band Imaging Alone In The Detection Of Visible Lesions Barrett's Esophagus: A Randomized Tandem Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Participants Who Had a Diagnostic Yield Obtained
研究概览
简要总结
The hypothesis is that the addition of a transparent cap to the end of the endoscope will increase the detection and diagnostic yield of visible lesions in Barrett's esophagus. Thus, the goal of this tandem design trial is to compare the diagnostic yield (DY) of cap assisted endoscopy with that of conventional endoscopy using high definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI) in patients with Barrett's esophagus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 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
- •Must be at least 18 years of age.
- •Must be patients undergoing standard of care EGD for the confirmation of dysplasia in BE or EET for dysplasia in BE.
- •Must be able to understand and willing to sign an IRB-approved written informed consent document.
排除标准
- •Pregnant or breastfeeding.
- •Prior endoscopic treatment for BE.
- •Unable to tolerate sedation due to medical comorbidities.
研究组 & 干预措施
Arm 1: EGD with cap first, followed by EGD without cap
-Participants in the first arm will undergo EGD with cap first, followed by EGD without cap in the same procedural period.
干预措施: Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI) (Procedure)
Arm 1: EGD with cap first, followed by EGD without cap
-Participants in the first arm will undergo EGD with cap first, followed by EGD without cap in the same procedural period.
干预措施: Olympus Disposable Distal Attachment Cap (Device)
Arm 2: EGD without cap first, followed by EGD with cap
-Participants in the second arm will undergo EGD without cap first, followed by EGD with cap in the same procedural period.
干预措施: Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI) (Procedure)
Arm 2: EGD without cap first, followed by EGD with cap
-Participants in the second arm will undergo EGD without cap first, followed by EGD with cap in the same procedural period.
干预措施: Olympus Disposable Distal Attachment Cap (Device)
结局指标
主要结局
Number of Participants Who Had a Diagnostic Yield Obtained
时间窗: At the time of procedure (day 1)
-Diagnostic yield is defined as Barrett's esophagus lesions that were identified and confirmed histologically as low grade dysplasia, high grade dysplasia, intramucosal cancer, or invasive adenocarcinoma
次要结局
- Number of Participants With High Grade Dysplasia or Esophageal Adenocarcinoma(At the time of procedure (day 1))
- Safety as Measured by Number of Participants With Procedure-related Adverse Events(Through 48 hours after EGD)
- Number of Participants With Visible Lesions in EGD With Cap Versus Without Cap(At the time of procedure (day 1))
- Total Procedure Duration in Seconds(At the time of procedure (day 1))