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2018-02-15
2018-02-15
2018-09-11
2
NCT06341725
IRCCS San Raffaele
IRCCS San Raffaele
OBSERVATIONAL
EUS Role in Non-metastatic Pancreatic Adenocarcinoma Lymph Nodes Staging
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 ȫORDERLINE resectable" and UNRESECTABLE non-metastatic (⊭vanced" 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)
Pathological lymph nodes will be assessed by EUS with elastography as lymph nodes: hypoechoic, rounded, rigid (blue) and big (bigger than 1 centimeter)
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-03-15 | N/A | 2024-03-25 |
2024-03-25 | N/A | 2024-04-02 |
2024-04-02 | N/A | 2024-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| CONCORDANCE (PERCENTAGE) of pathological lymph nodes at EUS with elastography and surgical pathology report | resectable pancreatic cancer | 2 years |
| OVERALL SURVIVAL (MONTHS) in metastatic lymph node presence | resectable pancreatic cancer | 2 years |
| OVERALL SURVIVAL (MONTHS) in metastatic lymph node presence | borderline resectable and locally advanced pancreatic cancer | 2 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| OVERALL SURVIVAL (MONTHS) | para-aortic and mediasitnum metastatic lymph nodes presence | 2 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
