EUS Role in Non-metastatic Pancreatic Adenocarcinoma Lymph Nodes Staging

March 25, 2024 updated by: Paolo Giorgio Arcidiacono, MD

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

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)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Other: malignant lymph nodes

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 Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- - Milan, Italy
    - IRCCS San Raffaele Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

pancreatic adenocarcinoma stage I-II and III with malignant lymph nodes assessed by EUS and elastography

Description

Inclusion Criteria: pancreatic adenocarcinoma without distant metastasis; patients > 18 years

Exclusion Criteria: distant metastasis and pancreatic adenocarcinoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OVERALL SURVIVAL (MONTHS) Time Frame: 2 years	para-aortic and mediasitnum metastatic lymph nodes presence	2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paolo Giorgio Arcidiacono, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2018

Primary Completion (Actual)

February 15, 2018

Study Completion (Actual)

September 11, 2018

Study Registration Dates

First Submitted

March 15, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)