Assessment of a Minimally Invasive Esophageal Cytology Collection System in Patients With Barrett's Esophagus or GERD Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 191
- 试验地点
- 10
- 主要终点
- Procedure Preference and Acceptability Questionnaire and Visual Analog Scale
研究概览
简要总结
This study will assess the Minimally Invasive Esophageal Cytology Collection System in Patients with Barrett's Esophagus or GERD Symptoms.
详细描述
This is a cross-sectional study of subjects with Barrett's esophagus (BE) to assess the utility of the Cytosponge device as a non-endoscopic method for collecting surface cells from the esophagus. This study will enroll 2 groups of subjects: 1) Subjects presenting for routine endoscopic BE surveillance examinations (n=120), and 2) Subjects with gastroesophageal reflux disease (GERD) symptoms undergoing upper endoscopy for screening for BE (n=55). After informed consent, and on the same day as the endoscopic procedure, the subject will undergo administration of the Cytosponge device and complete a questionnaire. The subject will then undergo routine upper endoscopy, with assessment of BE (where applicable), and biopsy per accepted surveillance or screening recommendations. The Cytosponge will be placed in fixative and shipped to an accredited pathology laboratory for embedding in paraffin and hematoxylin and eosin (H&E) staining to assess the adequacy of the specimen. Further evaluation of the specimen may be performed using trefoil factor 3 (TFF3). If the Cytosponge tissue specimen is inadequate, the subject will be recalled for a repeat sponge procedure (not endoscopy) 30 days later. Routine care tissue biopsies will undergo standard processing and H&E staining at the home institution, with assessment by expert gastrointestinal pathologists. Subjects will be contacted via phone 7 days (+/- 2 days) after Cytosponge administration to complete additional questionnaires and assess adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Male or female subjects, age 18 and above.
- •Able to read, comprehend, and complete the consent form.
- •Clinically fit for an endoscopy.
- •a) Previous confirmed diagnosis of Barrett's esophagus with intestinal metaplasia, and Prague classification of at least one circumferential centimeter of BE or a total BE segment length of at least 3 centimeters (C1+ or CXM3+) (BE arm) . OR b) If the subject does not have documented Prague Classification prior to screening, but the PI is convinced that the subject will meet the inclusion criteria based on previous documentation (for instance, mention of "long-segment BE," they may enroll the subject in the study at their discretion. The study upper endoscopy must confirm that the subject has C1+ or CXM3+ (BE arm). If (C1+ or CXM3+) is not observed at the time of study endoscopy, the subject may still be enrolled but not included in the data analysis with the BE cohort. The data may be analyzed in a separate cohort. OR c) Self-reported heartburn or regurgitation on at least a monthly basis for at least 6 months (GERD arm).
排除标准
- •Individuals with a diagnosis of an oropharynx, esophageal or gastro-esophageal tumor, or symptoms of dysphagia.
- •Any history of esophageal varices, stricture, or prior dilation of the esophagus.
- •Current use of anti-thrombotics (anti-coagulants and anti-platelet drugs) that cannot be safely discontinued for the appropriate drug-specific interval in the peri-administration period. Depending on the particular agent or reason for the anti-thrombotic therapy, it may not be necessary to discontinue anti-thrombotic agents. There could be circumstances where the drug may not need to be discontinued if the risk of bleeding is considered negligible (e.g. daily aspirin therapy). Physicians should use their clinical judgement and should consult guidelines such as those provided by the ASGE.
- •Known bleeding disorder.
- •Individuals who have had a myocardial infarction or any cardiac event < 6 months prior to enrollment.
- •Individuals who have had a cerebrovascular event < 6 months prior to enrollment in which swallowing was affected.
- •Prior ablative or resection therapy of the esophagus including radiofrequency ablation (RFA), photodynamic therapy (PDT), spray cryotherapy, endoscopic mucosal resection, and other ablation therapies.
- •Any history of esophageal surgery, except for uncomplicated fundoplication.
- •Do not need upper endoscopy as part of patient management.
研究组 & 干预措施
Patient wth Barrett's
Subjects presenting for routine endoscopic BE surveillance examinations
干预措施: Cytosponge™ Cell Collection Device (Device)
Patients with GERD
Subjects with gastroesophageal reflux disease (GERD) symptoms undergoing upper endoscopy for screening for BE
干预措施: Cytosponge™ Cell Collection Device (Device)
结局指标
主要结局
Procedure Preference and Acceptability Questionnaire and Visual Analog Scale
时间窗: Immediately post procedure up to 7 days +/- 3 days
The first primary objective of the study was to assess the acceptability of a novel, minimally invasive esophageal mucosal sampling technique, the Cytosponge™, in subjects undergoing surveillance of BE who have had at least a C1 or M3 segment confirmed, and 2) in subjects with GERD undergoing screening for BE. This includes measures of acceptability as demonstrated on the Impact of Event Scale, a Visual Analog Scale for Pain, and the subject's willingness to undergo repeat Cytosponge™ administration if it were offered to him/her. The Visual Analog Scale is measured from 0-100 scale for pain, 0 representing no pain and 100 representing the highest level of pain.
Number of Participants With Adequate Cytosponge™ Sample
时间窗: Immediately post procedure up to 7 days +/- 3 days
To assess the adequacy of cytology samples obtained by Cytosponge in this population after 1 sampling, and after 2 samplings if first sample inadequate.
次要结局
- Operating Characteristics(Immediately post procedure up to 7 days +/- 3 days)
- Cytosponge™ Operating Characteristics as a Function of Baseline Histology(Immediately post procedure up to 7 days +/- 3 days)
- Cytosponge™ Operating Characteristics vs Worst Histology Ever(Immediately post procedure up to 7 days +/- 3 days)
- Ongoing Safety Measures(Immediately post procedure up to 7 days +/- 3 days)
- Summary of Abrasion, Bleeding, and Perforation Observed Via Endoscopy(Immediately post procedure up to 7 days +/- 3 days)