A Pragmatic Interventional Study to Assess the Clinical Value of Capsule Sponge in the Assessment of Response to Treatment of Non-stenotic Eosinophilic Oesophagitis in a Single District General Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- • Descriptive Changes in clinical management of EOE following Capsule sponge assessment
研究概览
简要总结
Open pragmatic, descriptive single site study in adult patients with non-stenotic eosinophilic oesophagitis.
To assess the clinical value of Capsule sponge in the assessment of treatment response in patients with known non-stenosing eosinophilic oesophagitis, as an alternative to gastroscopy in a real world setting.
To assess patient preference for Capsule sponge or gastroscopy. All patients with non-stenosing eosinophilic oesophagitis who are reviewed in clinic that have not had reassessment of their oesophagus post treatment initiation or change in treatment will be offered Capsule sponge as an alternative to gastroscopy.
A standardised clinical symptom questionnaire will be self-administered for 2w prior to clinic visits and Capsule sponge.
Telephone triage for safety check and exclusion criteria by Capsule sponge nurse.
A patient symptom questionnaire at the time of procedure by research nurse. A patient satisfaction survey will be delivered after the Capsule sponge procedure by Capsule sponge nurse.
Cytological assessment of the Capsule sponge and eosinophil count and other markers of inflammation will be reported by Cyted.
Clinic follow up will occur at approximately 6-8 weeks post Capsule sponge. Descriptive Changes in management as a result of the Capsule sponge findings and /or symptoms will be recorded by clinician.
详细描述
Eosinophilic oesophagitis is a condition characterised by symptoms of dysphagia (swallowing difficulties) and/or food impaction in adults, with oesophageal biopsies (histology) showing a peak eosinophil count of >15 eosinophils/high power field (or >15 eosinophils/0.3mm2 or >60 eosinophils / mm2), and the absence of other causes of oesophageal.
Evidence suggests that if inadequately treated there is increased risk of oesophageal fibrosis and stricture formation that can lead to progressive dysphagia, food bolus obstruction (food blockages) and increased morbidity. The degree of eosinophil infiltration in the mucosa is thought to reflect the disease activity better than patient symptoms.
Current guidelines from Europe and newly published national guidelines from the British Society of Gastroenterology from the UK recommend reassessment of oesophageal eosinophilia after treatment to ensure remission This has traditionally involved repeating gastroscopies after each treatment (diet -after each food group, proton pump inhibitor (PPI), topical steroids) which is unpleasant for patients, expensive and labour intensive as well as producing a large carbon footprint.
Since the start of the COVID-19 pandemic in January 2020 there has been restricted or delayed access to gastroscopy nationally and consequently many patients with EOE have had their repeat gastroscopies cancelled or postponed, increasing the risk of complications from undertreated disease.
Capsule sponge (Cytosponge and Endosign being the current commercially produced example in the UK) is an oesophageal cell sampling device that is a 'pill on a string'. The patient swallows the pill with water and the sponge expands in the stomach. The nurse withdraws the string after 7 minutes and the sponge collects oesophageal cells on withdrawal. The sponge is sent for cytological analysis that identifies cells that can be stained for various biomarkers of Barrett's oesophagus (TFF3) and markers of dysplasia (p53 and atypia) as well as the opportunity to look at inflammation and in particular in this setting to assess the number of eosinophils and other histological and inflammatory markers supporting a diagnosis of 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
- Treatment
- 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 diagnosed with non -stenotic eosinophilic oesophagitis who have a change in treatment
排除标准
- •Strictures or rings at most recent endoscopy that prevent passage of adult gastroscope
- •Previous oesophageal dilatation
- •Previous oesophageal perforation or surgical resection
- •Oesophago-gastric malignancy
- •Oesophageal varices
- •Bolus obstruction since last endoscopy requiring hospital visit
- •Previous fundoplication or complicated hiatus hernia
- •Patient on Warfarin with INR>=3
- •Suspected new diagnosis of EOE without prior endoscopic confirmation
研究组 & 干预措施
all eligible patients with non stenotic eosinophilic oesophagitis
single arm observational study
干预措施: capsule sponge (Device)
结局指标
主要结局
• Descriptive Changes in clinical management of EOE following Capsule sponge assessment
时间窗: through study completion, an average of 1 year
has the results of the capsule sponge resulted in a decision to change treatment drug, or drug dose?-yes/ no response
patient preference for endoscopy or capsule sponge
时间窗: through study completion, an average of 1 year
tick box
• Eosinophil count on cytology
时间窗: through study completion, an average of 1 year
no of eosinophils per high powered field on cytology
• Patient pain evaluation
时间窗: through study completion, an average of 1 year
wong -baker faces visual scale from 0 to 10 with 0 being no pain and 10 being maximum pain
• symptom score
时间窗: through study completion, an average of 1 year
Dysphagia symptom score (DSQ) scored as continuous variable in 2 weeks prior to capsule sponge
次要结局
- • Inadequate sample rate(through study completion, an average of 1 year)
- • Complications(through study completion, an average of 1 year)
- • Failure to swallow rate(through study completion, an average of 1 year)
- • Repeat gastroscopy rate(through study completion, an average of 1 year)
- Cost evaluation(at end of study at 2 years)