Pancreatic AdenocarcinomaNCT06341725
EUS Role in Non-metastatic Pancreatic Adenocarcinoma Lymph Nodes Staging
An observational study of Pancreatic Adenocarcinoma and Lymph Node Metastasis, run by Paolo Giorgio Arcidiacono, MD at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Adenocarcinoma, Lymph Node Metastasis
- What is being tested?
- malignant lymph nodes
- How many people
- 2 participants
- Where
- 1 siteItaly
- Study dates
- 15 Feb 2018to 11 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: pancreatic adenocarcinoma stage I-II and III with malignant lymph nodes assessed by EUS and elastography
Inclusion Criteria: pancreatic adenocarcinoma without distant metastasis; patients > 18 years
Exclusion Criteria: distant metastasis and pancreatic adenocarcinoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the 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)
- Conditions
- Pancreatic Adenocarcinoma, Lymph Node Metastasis
- Being tested
- malignant lymph nodes
- Medical subject headings
- Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
malignant lymph nodesOther
observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
CONCORDANCE (PERCENTAGE) of pathological lymph nodes at EUS with elastography and surgical pathology report
resectable pancreatic cancer
Measured: 2 years
OVERALL SURVIVAL (MONTHS) in metastatic lymph node presence
resectable pancreatic cancer
Measured: 2 years
OVERALL SURVIVAL (MONTHS) in metastatic lymph node presence
borderline resectable and locally advanced pancreatic cancer
Measured: 2 years
Secondary outcomes (1)
OVERALL SURVIVAL (MONTHS)
para-aortic and mediasitnum metastatic lymph nodes presence
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start15 Feb 2018
- Primary completion15 Feb 2018
- Study completion11 Sep 2018
Why it stopped: no patients with inclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paolo Giorgio Arcidiacono, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paolo Giorgio Arcidiacono, MD, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341725
- Sponsor's protocol ID
- LinfoK EUS 2016
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Endoscopic Ultrasound to Assess the Lymph Nodes Staging in Non-metastatic Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06341725
- Acronym / sponsor ID
- LinfoK EUS 2016
- Conditions
- Pancreatic Adenocarcinoma, Lymph Node Metastasis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: no patients with inclusion criteria
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Paolo Giorgio Arcidiacono, MDUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 11 Sep 2018 (actual)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pancreatic adenocarcinoma stage I-II and III with malignant lymph nodes assessed by EUS and elastography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| malignant lymph nodesobservational study | Other | – |
Primary outcome
CONCORDANCE (PERCENTAGE) of pathological lymph nodes at EUS with elastography and surgical pathology report
Time frame: 2 years
resectable pancreatic cancer
OVERALL SURVIVAL (MONTHS) in metastatic lymph node presence
Time frame: 2 years
resectable pancreatic cancer
OVERALL SURVIVAL (MONTHS) in metastatic lymph node presence
Time frame: 2 years
borderline resectable and locally advanced pancreatic cancer
1 secondary outcome
OVERALL SURVIVAL (MONTHS)
Time frame: 2 years
Results and safety
The study was stopped early (reason given: no patients with inclusion criteria). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Adenocarcinoma and Lymph Node Metastasis, run by Paolo Giorgio Arcidiacono, MD at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: no patients with inclusion criteria). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CONCORDANCE (PERCENTAGE) of pathological lymph nodes at EUS with elastography and surgical pathology report (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.