Skip to content

EUS Role in Non-metastatic Pancreatic Adenocarcinoma Lymph Nodes Staging

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06341725
Enrollment
2
Registered
2024-04-02
Start date
2018-02-15
Completion date
2018-09-11
Last updated
2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymph Node Metastasis, Pancreatic Adenocarcinoma

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)

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)

Interventions

observational study

Sponsors

Paolo Giorgio Arcidiacono, MD
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

pancreatic adenocarcinoma without distant metastasis; patients \> 18 years

Exclusion criteria

distant metastasis and pancreatic adenocarcinoma

Design outcomes

Primary

MeasureTime frameDescription
CONCORDANCE (PERCENTAGE) of pathological lymph nodes at EUS with elastography and surgical pathology report2 yearsresectable pancreatic cancer
OVERALL SURVIVAL (MONTHS) in metastatic lymph node presence2 yearsresectable pancreatic cancer

Secondary

MeasureTime frameDescription
OVERALL SURVIVAL (MONTHS)2 yearspara-aortic and mediasitnum metastatic lymph nodes presence

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026