Trans-Oral Sampling as an Alternative Surveillance of Barrett's Esophagus Pilot: TOSS Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- to determine the number of sufficient quality samples obtained through the use of the Endosign, which could potentially serve as a substitute for endoscopic sampling.
研究概览
简要总结
The study aims to address the increasing incidence of esophageal cancer and Barrett's esophagus (BE) in the Western world by exploring a more efficient surveillance method. Esophageal adenocarcinoma (EAC) has a poor prognosis if diagnosed late, emphasizing the need for early detection strategies. Current surveillance methods, involving regular endoscopies, are burdensome and costly, particularly for low-risk patients. The study investigates the potential of the Endosign, a Trans Oral Sampling (TOS) device, as an alternative to endoscopic surveillance. The objective is to determine if Endosign can provide sufficient quality samples, containing columnar cells and clot preparations at least 5mm in size, thus offering a reliable substitute for endoscopic sampling. The study includes non-dysplastic and dysplastic BE patients undergoing surveillance or treatment and employs a single-center, prospective feasibility approach.
详细描述
Esophageal adenocarcinoma (EAC) has a poor prognosis when diagnosed at an advanced stage. Yet when EAC is identified at an early stage, patients can be treated endoscopically, reducing mortality and morbidity. However, the early detection currently relies on endoscopic surveillance, since there is no proper alternative.
Barrett's esophagus is the precursor lesion to EAC. Currently, all patients with Barrett's esophagus (BE) will undergo several esophagogastroduodenoscopies (EGD) in their lifetime compliant with the surveillance strategy for early cancer detection. However, the annual risk of high-grade dysplasia (HGD) or EAC for the Barrett's surveillance population is less than 1 percent. An assessment of the prevalence of EAC and BE by age group using data from more than 5 million people showed that the relative number of Barrett patients has increased substantially. This increase is not based on enhanced screening, but with the recent rise of better available screening tools, the number of patients diagnosed with BE is also expected to increase in the coming years. Both culminating in a high-volume surveillance population.
A cost-effectiveness analysis showed that for most patients with a low risk of developing EAC, it is not cost-effective to continue with the current surveillance strategy that requires patients to come back for endoscopy after a fixed interval. In addition to the costs associated with endoscopy, patients suffer anxiety and distress before their surveillance endoscopy. BE patients have a worse quality of life due to the overestimation of their risk of cancer. Patients should receive a surveillance strategy more aligned with their risk profile. But since there is not an adequate substitute for endoscopic surveillance, the current strategy is being continued. To relieve low risk-patients and ensure adequate utilization of health care resources, there is a need for a reliable alternative.
The Endosign, a sample collection device in class I , is a well-investigated transoral sampling device that can be administered easily and safely. Studies have been performed investigating the Endosign, a sample collection device in class I, for screening purposes. The tissue collected with the inexpensive tool showed to be well assessable for identifying BE patients. Transoral sampling is well-tolerated by patients. The device has shown great efficacy and cost-effectiveness. Nevertheless, the potential use for surveillance and risk stratification remains unclear.
The aim of this study is to investigate whether the tissue collected by the Endosign could be utilized in the detection of early cancer and identification of patients at increased risk of neoplastic progression. With good quality sampling using the Endosign, transoral sampling could be the alternative for endoscopic surveillance of Barrett's esophagus.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 age: ≥ 18 years
- •BE with a maximal extent of ≥4cm
- •Willingness to undergo an esophagogastroduodenoscopy with sedation
- •Cohort 1: Patients referred for endoscopic treatment of HGD or EAC
- •Cohort 2: Patients with known BE without a diagnosis of HGD or EAC in the previous 18 months, undergoing endoscopic surveillance
- •Ability to give written, informed consent and understand the responsibilities of participation
排除标准
- •Patients within eight weeks after endoscopy with biopsies and/or ER
- •History of esophageal or gastric surgery other than Nissen fundoplication
- •History of esophageal ablation or dilation therapy
- •Presence of esophageal varices and/or suspected portal hypertension
- •Dysphagia/ swallowing disorders
- •Pregnancy
- •Patients with known or suspected anatomical abnormalities of the esophagus or stomach
- •Patients taking anti-thrombotic drugs that cannot be temporarily discontinued
- •Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines
结局指标
主要结局
to determine the number of sufficient quality samples obtained through the use of the Endosign, which could potentially serve as a substitute for endoscopic sampling.
时间窗: 1year
The amount of samples collected with the Endosign that contain columnar cells and are processed to clot preparations that are at least 5mm in size.
次要结局
- To investigate the practicability of the trans oral sample procedure(1 year)
- Concordance of dysplasia detection between capsule sponge and standard endoscopic biopsy(1 year)
- Concordance of intestinal metaplasia detection(1 year)
- Intraobserver agreement for histologic findings in Capsule Sponge Samples(1 year)
- Intraobserver agreement of genomic markers(1 year)
研究者
Jacques J.G.H.M. Bergman
Head of Endoscopy Department, prof.dr. J.J.G.H.M. Bergman
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)