Diagnosis and Monitoring of Eosinophilic Esophagitis Using the Cytosponge
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 86
- 试验地点
- 4
- 主要终点
- Percent Agreement Between Cytosponge and Endoscopic Biopsy Results
研究概览
简要总结
The current endoscopic methods for diagnosing and monitoring treatment response in Eosinophilic Esophagitis (EoE) are costly, inconvenient, and risky. Novel diagnostic methods are needed, and the minimally-invasive Cytosponge holds great promise. It has been shown to be safe and accurate in Barrett's esophagus, it has the advantage (over the string test) of obtaining a true tissue sample, and our preliminary data supports its further study in EoE. The proposed prospective cohort study, conducted by experts in esophageal diseases and EoE, will assess the accuracy of Cytosponge compared to endoscopy and biopsy in EoE, and determine the safety and acceptability of this technique. Use of the Cytosponge would fundamentally change the paradigm for clinical management of EoE by allowing collection of non-endoscopic esophageal biopsies, thus minimizing the need for invasive testing. It would also facilitate future genetic, mechanistic, and pathogenesis research in EoE.
详细描述
Study design overview (all Aims) This will be a prospective cohort study, with patient enrollment conducted at UNC and Mayo Clinic with sample analysis performed by the University of Cambridge. In Aim 1, patients with EoE will be enrolled, tissue will be obtained from both the Cytosponge and endoscopy, and the methods will be compared for a single time point to determine accuracy of Cytosponge for quantifying esophageal eosinophil counts. For all patients, safety will be monitored and subjects will complete a survey about the acceptability of Cytosponge (Aim 2).
Cytosponge protocol:
After the study has been explained and a patient provides informed consent, the Cytosponge will be administered prior to endoscopy by trained research staff under physician supervision. If subjects opt to receive a local anesthetic, then they will be provided with a 2% lidocaine gargle prior to administration of the Cytosponge. The Cytosponge will be administered according to it's instructions for use. After retrieval, the string is cut and the sponge (which contains the tissue specimen) is placed in a container, immersed in fixative, and stored in a refrigerator at 4°C. The fixative is then spun in a centrifuge, and the pelleted cells are embedded in a paraffin block using standard techniques.
Upper endoscopy and biopsy:
After the Cytosponge has been removed, the patient will undergo standard of care (routine care) upper endoscopy and biopsy, as clinically indicated. During this exam, research staff will record all endoscopic features of EoE, including rings, furrows, white plaques, decreased vascularity, and strictures. The severity of the endoscopy findings will be measured using the recently validated endoscopic reference score (EREFS) scoring system. Four esophageal biopsies will be taken both from the distal (5 cm above the gastro-esophageal junction) and proximal (15 cm above the gastro-esophageal junction) esophagus. This number of biopsies has been shown to maximize the diagnostic sensitivity for EoE.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to read, comprehend, and complete the informed consent form
- •Male or female subjects, age 18-80 years,
- •Suspected EoE or has a diagnoses of EoE with current active disease,
排除标准
- •History of esophageal stricture precluding passage of the endoscope or sponge,
- •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 normalized ratio (INR) >1.3 and/or platelet count of <75,
- •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).
- •Are allergic to local anesthetics such as lidocaine (these subjects may opt not to receive the optional lidocaine gargle prior to the Cytosponge administration and still be eligible).
- •Have not fasted the night before administration of the Cytosponge.
- •History of perforation
结局指标
主要结局
Percent Agreement Between Cytosponge and Endoscopic Biopsy Results
时间窗: At study enrollment and initial procedure and each additional procedure, up to 1 year after enrollment
The primary outcome variables are sensitivity (percent agreement between positive results) and specificity (percent agreement between negative results) of the Cytosponge ability to detect the presence of EoE as compared to upper endoscopy with biopsy (the gold standard for diagnosis and monitoring of EoE). Overall agreement is defined as percentage of Cytosponge procedures yielding results consistent with endoscopic biopsy results. Presence of EoE is measured by the count of eosinophils present per high power field (eos/HPF) with active EoE defined as \>=15 eos/HPF. Sensitivity was calculated via percentage of positive (active EoE) results obtained via Cytosponge as compared to results indicating active EoE via endoscopy with biopsy. Specificity was calculated via percentage of negative (inactive EoE) results obtained via Cytosponge as compared to results indicating inactive EoE via endoscopy with biopsy.
次要结局
- Acceptability of Cytosponge as Measured by the Impact of Events Scale(7 days after each procedure)
- Overall Agreement Between Cytosponge and Endoscopic Biopsy Results as Measured by Kappa(At study enrollment and initial procedure and each additional procedure, up to 1 year after enrollment)
- Acceptability of Cytosponge Compared to Endoscopic Biopsy, as Measured by Visual Analog Scale(7 days after each procedure)