Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06341725
Status:
TERMINATED
Last Update Posted:
2024-04-02
First Post:
2024-03-15
Brief Title:
EUS Role in Non-metastatic Pancreatic Adenocarcinoma Lymph Nodes Staging
Sponsor:
Paolo Giorgio Arcidiacono MD
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Role of Endoscopic Ultrasound to Assess the Lymph Nodes Staging in Non-metastatic Pancreatic Adenocarcinoma
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no patients with inclusion criteria
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
Pathological lymph nodes will be assessed by EUS with elastography as lymph nodes hypoechoic rounded rigid blue and big bigger than 1 centimeter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None