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NCT06341725 Clinical Trial

EUS Role in Non-metastatic Pancreatic Adenocarcinoma Lymph Nodes Staging

Pancreatic Adenocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT06341725
Other study ID # LinfoK EUS 2016
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date February 15, 2018
Est. completion date September 11, 2018

Study information
Verified date March 2024
Source IRCCS San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)

Description:

Pathological lymph nodes will be assessed by EUS with elastography as lymph nodes: hypoechoic, rounded, rigid (blue) and big (bigger than 1 centimeter)

Recruitment information / eligibility
Status Terminated
Enrollment 2
Est. completion date September 11, 2018
Est. primary completion date February 15, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: pancreatic adenocarcinoma without distant metastasis; patients > 18 years Exclusion Criteria: distant metastasis and pancreatic adenocarcinoma

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• malignant lymph nodes
observational study

Locations
Country Name City State
Italy IRCCS San Raffaele Hospital Milan

Sponsors (1)
Lead Sponsor Collaborator
Paolo Giorgio Arcidiacono, MD

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary CONCORDANCE (PERCENTAGE) of pathological lymph nodes at EUS with elastography and surgical pathology report resectable pancreatic cancer 2 years
Primary OVERALL SURVIVAL (MONTHS) in metastatic lymph node presence resectable pancreatic cancer 2 years
Primary OVERALL SURVIVAL (MONTHS) in metastatic lymph node presence borderline resectable and locally advanced pancreatic cancer 2 years
Secondary OVERALL SURVIVAL (MONTHS) para-aortic and mediasitnum metastatic lymph nodes presence 2 years
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