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临床试验/NCT06341725
NCT06341725终止不适用

Role of Endoscopic Ultrasound to Assess the Lymph Nodes Staging in Non-metastatic Pancreatic Adenocarcinoma

Paolo Giorgio Arcidiacono, MD1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2018年2月15日最近更新:
适应症

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

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

发起方
Paolo Giorgio Arcidiacono, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Paolo Giorgio Arcidiacono, MD

Professor

IRCCS San Raffaele

研究点 (1)

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