Study Stopped
no patients with inclusion criteria
EUS Role in Non-metastatic Pancreatic Adenocarcinoma Lymph Nodes Staging
Role of Endoscopic Ultrasound to Assess the Lymph Nodes Staging in Non-metastatic Pancreatic Adenocarcinoma
1 other identifier
observational
2
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 11, 2018
CompletedFirst Submitted
Initial submission to the registry
March 15, 2024
CompletedFirst Posted
Study publicly available on registry
April 2, 2024
CompletedApril 2, 2024
March 1, 2024
Same day
March 15, 2024
March 25, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
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 (1)
OVERALL SURVIVAL (MONTHS)
2 years
Interventions
observational study
Eligibility Criteria
pancreatic adenocarcinoma stage I-II and III with malignant lymph nodes assessed by EUS and elastography
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS San Raffaele Hospital
Milan, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 15, 2024
First Posted
April 2, 2024
Study Start
February 15, 2018
Primary Completion
February 15, 2018
Study Completion
September 11, 2018
Last Updated
April 2, 2024
Record last verified: 2024-03