EUS Role in Non-metastatic Pancreatic Adenocarcinoma Lymph Nodes Staging

Terminated

• Conditions: Pancreatic Adenocarcinoma; Lymph Node Metastasis

• Registration Number: NCT06341725
• Lead Sponsor: Paolo Giorgio Arcidiacono, MD

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)

Study Timeline

• Study Start: 2018-02-15
• Primary Completion: 2018-02-15
• Study Completion: 2018-09-11
• Status Verified: 2024-03
• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-03-25
• Last Update Submitted: 2024-03-25
• Study First Posted: 2024-04-02
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

pancreatic adenocarcinoma without distant metastasis; patients > 18 years

Exclusion Criteria

distant metastasis and pancreatic adenocarcinoma

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CONCORDANCE (PERCENTAGE) of pathological lymph nodes at EUS with elastography and surgical pathology report	2 years	resectable pancreatic cancer
OVERALL SURVIVAL (MONTHS) in metastatic lymph node presence	2 years	borderline resectable and locally advanced pancreatic cancer

Secondary Outcome Measures

Name	Time	Method
OVERALL SURVIVAL (MONTHS)	2 years	para-aortic and mediasitnum metastatic lymph nodes presence

Trial Locations

Locations (1)

IRCCS San Raffaele Hospital; 🇮🇹 Milan, Italy