EUS-Elastography and Contrast-Enhanced EUS Diagnostic Accuracy in the Differential Diagnosis of Subepithelial Gastrointestinal Tumors: a Multicenter Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 7
- 主要终点
- Evaluation of EUS-E accuracy qualitative
研究概览
简要总结
This will be a longitudinal, prospective, observational multicenter study where the role of EUS-E will be examined in differentiating subepithelial gastrointestinal tumors in 138 patients
详细描述
This will be a longitudinal, prospective, observational multicenter study that will enroll consecutive patients, with gastrointestinal SETs diagnosed by experienced endoscopists at Italian hospitals. This study will be conducted following the Helsinki Declaration after the approval by the ethics review board of all centers and will be recorded on Clinical-Trials.gov. All patients will provide their written informed consent for participating in the study. The EUS-E and CEUS analysis with SonoVue® will be performed during the same procedures. A subsequent diagnostic hypothesis on the nature of SETs will be formulated based on the B-mode, EUS-E, and CE-EUS characteristics.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with GI SETs scheduled for EUS-FNB 2 Patients with age > 18 but <85
排除标准
- •Patients with GI SETs <15mm
- •severe coagulopathy defined as abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma
- •severe cardiopulmonary diseases and severe chronic kidney disease defined as
- •known allergic disposition to SonoVue®
结局指标
主要结局
Evaluation of EUS-E accuracy qualitative
时间窗: 4 weeks
Evaluation of Endoscopic Ultrasound -Elastography (EUS-E)) accuracy (qualitative elastography) and contrast enhanced endoscopic ultrasound (CE-EUS) in the diagnosis of SETs compared to the histological data provided by the ultrasound-guided biopsy. the elastographic qualitative pattern will be assessed and described using an elastographic score. ELASTOGRAPHIC SCORE: three elastographic patterns will be used to define the stiffness of the SETs: * homogeneously green-pattern (soft) * mixed-type pattern (mild stiffness) * blue-predominant elastographic pattern (hard) Strain Ratio (SR) will be calculated by dividing the ROI placed on the normal GI wall at the periphery of the mass (ROI B) by the ROI placed on the lesion itself (ROI A). ROI A will be manually adjusted to cover the tumoral area as much as possible.
Evaluation of EUS-E accuracy quantitative
时间窗: 4 weeks
Evaluation of Endoscopic Ultrasound -Elastography (EUS-E) accuracy (quantitative elastography) and contrast enhanced endoscopic ultrasound (CE-EUS) in the diagnosis of SETs compared to the histological data provided by the ultrasound-guided biopsy. EUS-E compares the strain between the target area and other reference areas, to provide a semi-quantitative analysis of tissue stiffness. The SR (B/A quotients) will be calculated by the diagnostic US imaging system. The SRs will be measured and recorded 3 times in each procedure; the mean value will be considered as the final result for data analysis(to establish an SR cut-off to differentiate GIST from other SETs). Videos of 5 seconds will be recorded per each measurement.
次要结局
- Complication rate (perforations, bleeding) of the procedure(48 hours)
- Evaluation of diagnostic accuracy of EUS-biopsy with fine needle biopsy (FNB)(4 weeks)
- Evaluation of gene mutations in EUS-guided specimen(24 weeks)
- Correlation of elastographic and contrastographic characteristics of SETs with the pathological risk stratification.(24 weeks)