Early Detection of Barrett's Esophagus and Esophageal Cancer: Accuracy and Acceptability of a Novel Screening Strategy in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 449
- 试验地点
- 2
- 主要终点
- Positive Predictive Value (PPV) of the eNose for detecting confirmed BE
研究概览
简要总结
In the Netherlands, the incidence of esophageal adenocarcinoma (EAC) is increasing. In addition, EAC has a dismal prognosis. Therefore, screening for Barrett's Esophagus (BE) has stimulated interest. Although BE is a known precursor of EAC, a minority of patients with EAC are known with a previous diagnosis of BE. A non-invasive screening tool, such as breath testing, could select patients at risk for BE, after which unsedated transnasal endoscopy (uTNE) can confirm or exclude the diagnosis. The objective is to determine the accuracy and acceptability of a non-invasive screening strategy i.e. breath testing followed by uTNE for BE and EAC.
详细描述
The ongoing increasing incidence of esophageal adenocarcinoma (EAC) in the Netherlands during the last few decades and the still dismal prognosis has stimulated interest in screening for Barrett's esophagus (BE). Although BE is a known precursor of EAC, a minority of patients with EAC (<10%) are known with a previous diagnosis of BE, and hence, most cases of BE are undiagnosed. Screening programs to detect BE followed by endoscopic surveillance and treatment of dysplasia or early neoplasia seem able to reduce the incidence of EAC and improve survival. A non-invasive screening tool, such as breath testing, could select patients at risk for BE, after which unsedated transnasal endoscopy (uTNE) can confirm or exclude the diagnosis. uTNE offers the possibility of a more acceptable and accurate endoscopic assessment of the esophagus with almost neglectable risks and lower costs compared to conventional endoscopy. The objective is to determine the accuracy and acceptability of a non-invasive screening strategy i.e. breath testing followed by uTNE for BE and EAC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 50 to 75 years;
- •Recorded diagnosis of reflux symptoms >90 days OR
- •Recorded prescriptions for acid suppressant therapy for this indication for at least 1 year in the past 5 years
- •Written informed consent.
排除标准
- •Upper endoscopy in the previous 5 years;
- •A current or previous diagnosis and/or treatment of any type of malignancy (not including basal-cell skin cancer (BCC) and squamous-cell skin cancer (SCC)) within the last five years;
- •Already known with a diagnosis of Barrett's esophagus or gastro-esophageal cancer;
- •Any argument provided by a patient's own general practitioner not to include the patient;
- •Comorbidities precluding transnasal endoscopy (e.g. inability to discontinue oral anticoagulants, history of recurrent epistaxis, allergy to lidocaine derivatives).
结局指标
主要结局
Positive Predictive Value (PPV) of the eNose for detecting confirmed BE
时间窗: 16 weeks after breath test (eNose)
PPV of the eNose for detecting confirmed BE with the diagnosis made by transnasal endoscopy and upper endoscopy as the reference standard in primary care.
Negative Predictive Value (NPV) of the eNose for detecting confirmed BE
时间窗: 16 weeks after breath test (eNose)
NPV of the eNose for detecting confirmed BE with the diagnosis made by transnasal endoscopy and upper endoscopy as the reference standard in primary care.
Specificity of the eNose for detecting confirmed BE
时间窗: 16 weeks after breath test (eNose)
Specificity of the eNose for detecting confirmed BE with the diagnosis made by transnasal endoscopy and upper endoscopy as the reference standard in primary care.
Sensitivity of the eNose for detecting confirmed BE
时间窗: 16 weeks after breath test (eNose)
Sensitivity of the eNose for detecting confirmed BE with the diagnosis made by transnasal endoscopy and upper endoscopy as the reference standard in primary care.
次要结局
- Rate of successful evaluation by uTNE(1 week after the last participant undergoes uTNE.)
- Willingness to undergo repeat uTNE procedure(Directly after uTNE)
- Safety of uTNE based on reported Adverse Events.(1 week after the last participant undergoes uTNE.)
- Patient acceptability (discomfort and overall experience) of uTNE measured on a NPRS.(Directly after uTNE)
- Anxiety (STAI-6)(At baseline, 7 days after eNose, 7 days after uTNE, 7 days after conventional endoscopy (if applicable), 30 days after eNose, 30 days after uTNE, 30 days after conventional endoscopy (if applicable), 90 days after last study procedure.)
- Patient acceptability (discomfort and overall experience) of conventional endoscopy (if applicable) measured on a NPRS.(Directly after conventional endoscopy)
- Cancer worry (CWS-8)(At baseline, 7 days after eNose, 7 days after uTNE, 7 days after conventional endoscopy (if applicable), 30 days after eNose, 30 days after uTNE, 30 days after conventional endoscopy (if applicable), 90 days after last study procedure.)
- Impact of event (IES-15)(7 days after eNose, 7 days after uTNE, 7 days after conventional endoscopy (if applicable), 30 days after eNose, 30 days after uTNE, 30 days after conventional endoscopy (if applicable), 90 days after last study procedure.)
- Patient acceptability (discomfort and overall experience) of the eNose measured on a NPRS.(Directly after breath test (eNose))
- Willingness to undergo repeat eNose procedure(Directly after breath test (eNose))
- Rate of successful evaluation by breath test (eNose)(1 week after the last participant undergoes breath test (eNose).)
- Safety of eNose based on reported Adverse Events.(1 week after the last participant undergoes breath test (eNose).)
- Willingness to undergo repeat conventional endoscopy(Directly after conventional endoscopy)