Study to Compare the Efficacy and Patient Tolerance of Ultrathin Nasal Endoscopy to Detect Barrett's Esophagus Compared With Conventional Endoscopy to Inform a Future Multicentre Screening Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 主要终点
- Endoscopic Diagnostic Accuracy for Barrett's esophagus
研究概览
简要总结
This study evaluates the diagnostic accuracy, safety and acceptability of transnasal endoscopy (TNE) for a diagnosis of Barrett's esophagus (BE). This is a cross-over randomised trial, whereby patients receive two endoscopic procedures 2-4 weeks apart and will be randomised to receive either TNE or standard endoscopy followed by the other procedure.
详细描述
Background: The incidence of esophageal adenocarcinoma (EAC) has drammatically increased in the Western World in the last 30 years. Furthermore it often presents in the late stages and the prognosis remains poor with an overall 5-year survival of 10-15%. Early detection is possible since most cases of EAC develop from a precursor condition, Barrett's esophagus (BE), via a metaplasia-dysplasia-adenocarcinoma sequence. BE can be diagnosed with an upper GI endoscopy.
Un-sedated trans-nasal endoscopy (TNE) may be safer and less expensive than standard endoscopy (SE) for detecting BE. Emerging technologies require robust evaluation before routine use.
Objective: To evaluate the sensitivity, specificity, and acceptability of TNE in diagnosing BE compared with those of SE.
Design:Prospective, randomized, crossover study
Setting:Single, tertiary-care referral center.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: > 18 years and <75 years
- •Patients who have given informed consent and who are capable of filling in the questionnaire.
- •Patients requiring endoscopy for dyspepsia or follow-up evaluation and patients with a prior diagnosis of BE (defined as minimum Barrett's length of 2cm - according to M level of Prague C & M classification) with specialized intestinal metaplasia on histological confirmation.
排除标准
- •Previous upper GI tract or upper respiratory tract surgery or known upper GI tract abnormality (e.g. pharyngeal pouch).
- •Coagulopathy or on anticoagulants
- •Active or severe cardiopulmonary disease or liver disease
- •Active GI bleeding
- •Patients with alarm symptoms referred to the fast track service and any patient with dysphagia
- •Patients requiring possible endoscopic therapy
- •Patients with high-grade dysplasia or intramucosal carcinoma in BE requiring extensive evaluation and biopsy
结局指标
主要结局
Endoscopic Diagnostic Accuracy for Barrett's esophagus
时间窗: 2 weeks
Sensitivity and specificity for detecting BE using ultrathin endoscopy when compared to gold standard conventional endoscopy will be calculated along with 95% Pearson-Clopper confidence intervals.
次要结局
- Optical accuracy(2 weeks)
- Histological diagnosis of Barrett's esophagus(2 weeks)
- Patient acceptability(12 weeks)
- Adverse events(1 week)
研究者
Massimiliano di Pietro, MD
Senior Clinician Scientist and Consultant Gastroenterologist
University of Cambridge