EUS Role in Non-metastatic Pancreatic Adenocarcinoma Lymph Nodes Staging

NCT ID: NCT06341725

Last Updated: 2024-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-15

Study Completion Date

2018-09-11

Brief Summary

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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

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

Conditions

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Pancreatic Adenocarcinoma Lymph Node Metastasis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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malignant lymph nodes

observational study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria: distant metastasis and pancreatic adenocarcinoma
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Paolo Giorgio Arcidiacono, MD

OTHER

Sponsor Role lead

Responsible Party

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Paolo Giorgio Arcidiacono, MD

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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IRCCS San Raffaele Hospital

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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LinfoK EUS 2016

Identifier Type: -

Identifier Source: org_study_id

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