EUS Role in Non-metastatic Pancreatic Adenocarcinoma Lymp... | NCT06341725

Studies
EUS Role in Non-metastatic Pancreatic Adenocarcinoma Lymph Nodes Staging

NCT06341725

Sponsor

Paolo Giorgio Arcidiacono, MD

Status

Terminated

Last Update Posted

Apr 2, 2024Actual

Enrollment

2Actual

Phase

Not provided

Conditions

Pancreatic Adenocarcinoma
Lymph Node Metastasis

Interventions

malignant lymph nodes

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

no patients with inclusion criteria

Expanded Access Info

Start Date

Feb 15, 2018Actual

Primary Completion Date

Feb 15, 2018Actual

Completion Date

Sep 11, 2018Actual

First Submitted Date

Mar 15, 2024

First Submission Date that Met QC Criteria

Mar 25, 2024

First Posted Date

Apr 2, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2024

Last Update Posted Date

Apr 2, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Paolo Giorgio Arcidiacono, MD, Professor, IRCCS San RaffaeleSponsor-Investigator

Lead Sponsor

Paolo Giorgio Arcidiacono, MDOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
malignant lymph nodes	Other	observational study

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Exclusion Criteria: distant metastasis and pancreatic adenocarcinoma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS San Raffaele Hospital		Milan			Italy

Condition Browse Module

MeSH Terms

ID	Term
D008207	Lymphatic Metastasis

Ancestor Terms

ID	Term
D009362	Neoplasm Metastasis
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes

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