Role of Endoscopic Ultrasound to Assess the Lymph Nodes Staging in Non-metastatic Pancreatic Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- CONCORDANCE (PERCENTAGE) of pathological lymph nodes at EUS with elastography and surgical pathology report
研究概览
简要总结
Aim of the study will be to investigate if Endoscopic Ultrasound (EUS) with elastography can be purposed between the routine staging examinations in patients with pancreatic adenocarcinoma without distant metastasis for the staging of lymph nodes status ("N" in TNM classification)
- in RESECTABLE pancreatic cancer the investigators will evaluate the concordance with EUS elastography and histological findings of lymph nodes obtained during surgery, in order to assess the sensibility, specificity and the positive and negative predictive value of EUS with elastography, the disease-free survival, the percentage of metastatic patients and the overall survival (in patients with or without metastatic lymph nodes).
- in "BORDERLINE resectable" and UNRESECTABLE non-metastatic ("advanced" locally") disease, the investigators will evaluate if the malignant lymph nodes samples during EUS with elastography and fine needle aspiration (FNA) will be related to a decreased survival.
Secondary aim will be to register the prognosis (in terms of survival) of the patients with para-aortic and mediastinal pathological lymph nodes (related to a decreases survival in some series in literature)
详细描述
Pathological lymph nodes will be assessed by EUS with elastography as lymph nodes: hypoechoic, rounded, rigid (blue) and big (bigger than 1 centimeter)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pancreatic adenocarcinoma without distant metastasis; patients > 18 years
排除标准
- •distant metastasis and pancreatic adenocarcinoma
结局指标
主要结局
CONCORDANCE (PERCENTAGE) of pathological lymph nodes at EUS with elastography and surgical pathology report
时间窗: 2 years
resectable pancreatic cancer
OVERALL SURVIVAL (MONTHS) in metastatic lymph node presence
时间窗: 2 years
borderline resectable and locally advanced pancreatic cancer
次要结局
- OVERALL SURVIVAL (MONTHS)(2 years)
研究者
Paolo Giorgio Arcidiacono, MD
Professor
IRCCS San Raffaele
