Patient Acceptance and Preference Among Screening Modalities for Detection of Barrett's Esophagus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- 7 Days Post-EGD Impact of Events Score (IES)
研究概览
简要总结
To assess patient acceptance and preference among screening modalities, Esophagogastroduodenoscopy (EGD), Transnasal Esophagoscopy (TNE), and Cytosponge for Barrett's esophagus (BE). Subjects will undergo administration of Cytosponge and transnasal endoscopy (TNE) prior to their scheduled clinically indicated upper endoscopy performed per routine standard of care. Following the procedure, a follow-up phone call will be made during which an impact of events scale related to the subjective distress of each procedure, a preference and acceptance questionnaire, and adverse events related to study participation will be collected.
详细描述
Potential subjects will be identified via protocol and Institutional Review Board (IRB) methods prior to obtaining written informed consent. Once written informed consent is obtained and baseline demographic and medical history is collected, subjects will undergo administration of Cytosponge and transnasal endoscopy (TNE) prior to their scheduled clinically indicated upper endoscopy performed per routine standard of care. Following the procedure, a follow-up phone call will be made during which an impact of events scale related to the subjective distress of each procedure, a preference and acceptance questionnaire, and adverse events related to study participation will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Patients with one of the following: Gastroesophageal Reflux Disease (GERD) OR Barrett's esophagus (BE)
- •At least 18 years of age at time of consent
- •Able and willing to provide written informed consent
- •Able and willing to comply with required study procedures and follow-up schedule
- •Presenting to UNC Hospitals for routine care upper endoscopy
排除标准
- •History of pre-existing esophageal stenosis/ stricture, esophageal diverticulum or significant esophageal anatomic abnormalities (masses, obstructive lesions, etc.)
- •History of head and neck malignancy or anatomical abnormalities of the nasopharynx
- •Any history of Ear, Nose and Throat (ENT) surgery
- •History of significant epistaxis or hereditary hemorrhagic telangiectasia (HHT)
- •Sinus or pulmonary infection in the last 4 weeks
- •Current use of blood thinners such as coumadin, warfarin, clopidogrel, heparin and/or low molecular weight heparin (requires discontinuation of medication 7 days prior to and 7 days after esophagogastroduodenoscopy [EGD] and Cytosponge administration, aspirin use is OK).
- •Known bleeding disorder
- •Pregnancy, or planned pregnancy during the course of the study.
- •Any history of esophageal varices, liver impairment of moderate or worse severity (Child's- Pugh class B & C) or evidence of varices noted on any past endoscopy
- •Any history of esophageal surgery, except for uncomplicated fundoplication
- •History of coagulopathy, with international normalised ratio (INR) >1.3 and/or platelet count of <75,000
- •General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation
- •Subject has any condition that, in the opinion of the investigator or sponsor, would interfere with accurate interpretation of the study objectives or preclude participation in the trial
结局指标
主要结局
7 Days Post-EGD Impact of Events Score (IES)
时间窗: 7 days post-EGD
Impact of Events Score (IES): scale was developed to assess the distress associated with a specific life event. IES scores range from 0-75, with higher scores indicating more severe distress associated from an event. Scores ≥ 44 indicate a event has severe impact on self-reported distress while scores ≤ 25 indicate the event may have an effect on distress.
次要结局
- Visual Analog Scale (VAS) Score(Day 1, Post-procedure (<24 hours of procedure completion))
- Factors Influencing the Preferred Screening Modality(7 days post-EGD)
- 7 Days Post-EGD Ranking of Preferred Screening Modality(7 days post-EGD)
- 7 Days Post-EGD Willingness to Repeat(7 days post-EGD)
- Number of Participants Reporting Preferred Screening Modality(7 days post-EGD)