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临床试验/NCT02852525
NCT02852525已完成不适用

Real-Time Evaluation of Barrett's Esophagus by Confocal Laser Probe-based Microscopy

Virendra Joshi4 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
4
主要终点
Sensitivity and Specificity of probe based endomicroscopy as compared to histopathology in diagnosing Barrett's metaplasia

研究概览

简要总结

The purpose of this study is to further validate the use of probe-based confocal laser endomicroscopy (pCLE) for the evaluation of Barrett's Esophagus and associated neoplasia in a larger patient base.

详细描述

Subject Population

Approximately 100 subjects will be recruited, age greater than 18 years. Subjects will be recruited from OCF, OMC Kenner who are undergoing EGD for either 1) screening for Barrett's Esophagus because of long-standing GERD of greater than 5 years; 2) surveillance of known Barrett's Esophagus; or 3) therapy for known Barrett's Esophagus. They will be asked to volunteer for participation at the time of their EGD. These subjects are being recruited because of a high suspicion or known diagnosis of Barrett's Esophagus in this cohort.

Procedures

Patients agreeing to participate in the research study will receive an additional intravenous injection during endoscopy. This dose of 2.5 mg of IV fluorescein will be administered during their EGD. Probe-based microscopy will be used to evaluate the mucosa of the esophagus and GE junction. Photographs will be taken and digitally stored. Biopsies (which are part of the routine diagnosis and surveillance of Barrett's) will be targeted based on the microscopic images. The histologic findings on the biopsy specimens will be compared to the microscopic images to determine the accuracy of the probe-based microscopy in predicting pathology.

The time commitment for the patient is included in the time to undergo endoscopy and is roughly 30 minutes to an hour, including recovery time. The research will occur at OMC, Jefferson Highway and Ochsner Medical Center, Kenner.

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must be greater than 18 years of age
  • currently undergoing EGD
  • previous diagnosis of Barrett's Esophagus
  • long-standing GERD of greater than 5 years
  • undergoing therapy for previously diagnosed Barrett's Esophagus

排除标准

  • Under 19 years of age

结局指标

主要结局

Sensitivity and Specificity of probe based endomicroscopy as compared to histopathology in diagnosing Barrett's metaplasia

时间窗: 30 minutes up to an hour on average after undergoing endoscopy

次要结局

  • Tissue and blood Biomarker evaluation in targeted biopsies obtained at endomicroscopy in patients diagnosed to have Barrett's metaplasia and dysplasia(30 minutes up to an hour on average after undergoing endoscopy)

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Virendra Joshi

Virendra Joshi,MD

Ochsner Health System

研究点 (4)

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