The Use of Volumetric Laser Endomicroscopy to Predict Recurrence of Barrett's Esophagus After Complete Eradication of Intestinal Metaplasia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Determine association between distribution of glandular structures measured with volumetric laser endomicroscopy and recurrence of Barrett's esophagus following endoscopic therapy
研究概览
简要总结
Researchers are trying to see if the Nvision® Imaging System (VLE) can accurately determine the risk of recurrent Barrett's esophagus in patients with Barrett's esophagus which have been clear of disease.
详细描述
Patients with Barrett's Esophagus (BE) undergoing endoscopic therapy through our Barrett's Esophagus Unit will be approached for study enrollment. Patients with no endoscopic evidence of BE will be considered for the study. Surveillance biopsies will be obtained per standard clinical protocol and reviewed to confirm absence of intestinal metaplasia. Patients who have achieved complete eradication of intestinal metaplasia (CRIM) will be enrolled in the study and will undergo the Nvision® Imaging System (VLE). Patients enrolled in the study will undergo clinical follow-up consisting of surveillance endoscopy every 3 months for 1 year. Surveillance endoscopy intervals may be prolonged to every 6 months in the second year, and annually thereafter. At each follow-up visit, endoscopic data will be collected to determine if patients remain in CRIM or show evidence of recurrent disease. Patients will be followed for 1 year (endpoint 1) and 3 years (endpoint 2).
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研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Patient undergoing an upper endoscopy with prior biopsy confirmed Barrett's Esophagus.
- •Ability to provide written, informed consent
- •No significant esophagitis (LA grade <B, C, and D)
排除标准
- •Patients for whom use of the NvisionVLE device would be in conflict with the instruction for use.
- •Prior esophageal or gastric surgical resection
- •Significant esophageal stricture requiring dilatation
- •Patients who require anti-coagulation for who biopsy would be contraindicated
- •Patients who are known to be pregnant
结局指标
主要结局
Determine association between distribution of glandular structures measured with volumetric laser endomicroscopy and recurrence of Barrett's esophagus following endoscopic therapy
时间窗: 1 year
Measure the distribution (gastric cardia versus esophagus) of glandular structures observed with volumetric laser endomicroscopy in patients who remain free of Barrett's esophagus and in those with recurrent disease. Report the mean and standard-deviation of this metric and determine a statistical significant difference using the Student's t-test.
Determine association between thickness of neosquamous epithelium measured with volumetric laser endomicroscopy and recurrence of Barrett's esophagus following endoscopic therapy
时间窗: 1 year
Measure the thickness of neosquamous epithelium (mm) with volumetric laser endomicroscopy in patients who remain free of Barrett's esophagus and in those with recurrent disease. Report the mean and standard-deviation of this metric and determine a statistical significant difference using the Student's t-test.
Determine association between number of glandular structures measured with volumetric laser endomicroscopy and recurrence of Barrett's esophagus following endoscopic therapy
时间窗: 1 year
Measure the number of glandular structures observed with volumetric laser endomicroscopy in patients who remain free of Barrett's esophagus and in those with recurrent disease. Report the mean and standard-deviation of this metric and determine a statistical significant difference using the Student's t-test.
次要结局
- Develop a volumetric laser endomicrosopy feature scoring index to stratify the risk of disease recurrence in patients with Barrett's esophagus following treatment(3 years)
研究者
Cadman Leggett
Principal Investigator
Mayo Clinic