Role of Endoscopic Ultrasound-guided Detective Flow Imaging (EUS-DFI) for the Evaluation of Solid Pancreatic Tumours: A Prospective, International Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 主要终点
- DFI vascularization pattern
研究概览
简要总结
This prospective, international, multicenter observational study aims to evaluate the role of Endoscopic Ultrasound-guided Detective Flow Imaging (EUS-DFI) in the characterization of solid pancreatic lesions. The study will assess microvascularization patterns identified by EUS-DFI and their association with the final diagnosis, using histopathology or clinical follow-up as the reference standard. Secondary objectives include evaluating interobserver agreement and the diagnostic accuracy of DFI vascular patterns for differentiating benign and malignant pancreatic lesions.
详细描述
Endoscopic ultrasound (EUS) is an essential technique for the evaluation of pancreatic lesions. However, conventional B-mode imaging alone is often insufficient to accurately differentiate the various types of solid pancreatic tumors, making tissue acquisition necessary in many cases. Despite the high diagnostic accuracy of EUS-guided sampling, false-negative results may occur and repeated sampling can be required.
Detective Flow Imaging (DFI) is a novel ultrasound technology that enables visualization of microvascularization without the use of contrast agents by detecting low-velocity blood flow while minimizing motion artifacts. Preliminary evidence suggests that DFI may improve lesion characterization, but data regarding its application in solid pancreatic lesions remain limited.
This is a prospective, international, multicenter observational study including adult patients undergoing routine EUS in whom a solid pancreatic lesion is identified. All participants will undergo standard EUS evaluation, EUS-guided DFI assessment, and tissue acquisition according to routine clinical practice. DFI findings will be correlated with the final diagnosis established by surgical pathology, EUS-guided tissue sampling, or comprehensive clinical, imaging, and laboratory follow-up of at least six months.
The primary objective is to characterize DFI microvascularization patterns according to the histological diagnosis of solid pancreatic lesions. Secondary objectives include assessing interobserver agreement among investigators and determining the diagnostic performance of DFI vascular patterns for differentiating malignant from benign pancreatic lesions.
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
- •Adults aged 18 years or older.
- •Presence of a solid pancreatic lesion identified during endoscopic ultrasound (EUS), regardless of the indication for the examination.
- •Ability and willingness to provide written informed consent.
排除标准
- •Predominantly cystic pancreatic lesions.
- •Anatomical abnormalities preventing adequate EUS examination.
- •Limited ability to understand the study procedures or provide informed consent.
- •Refusal to sign the informed consent form.
结局指标
主要结局
DFI vascularization pattern
时间窗: At the time of the EUS procedure
Classification of vascularization pattern as hypovascular, isovascular, hypervascular or indeterminate on DFI.
Presence of vessels
时间窗: At the time of the EUS procedure
Presence or absence of vessels identified on DFI.
Vessel distribution
时间窗: At the time of the EUS procedure
Classification of vessel distribution as intratumoral or peritumoral on DFI.
次要结局
- Interobserver agreement for DFI vascular pattern classification(Up to 6 months)
- Diagnostic accuracy of DFI vascular patterns for malignancy(Up to 6 months)
研究者
Julio Iglesias García
Head of Endoscopy Unit
Hospital Clinico Universitario de Santiago
