Pancreas CancerPALNNCT06065891
Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer
A study testing PALN resection in people with Pancreas Cancer and Pancreas Adenocarcinoma, run by Jon Unosson at 6 sites in 2 countries.
Trial summary
Lymph node metastases are a strong prognostic predictor for pancreatic cancer. Para-aortic lymph nodes (PALN) are the final nodes for periampullary cancers before the cancer cells enter the systemic lymphatic circulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Pancreas Adenocarcinoma, Lymph Node Metastasis
- What is being tested?
- PALN resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 5 Sep 2023to 5 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resectable suspected periampullary cancer (requiring duodenopancreatectomy) (NCCN guidelines 2020)
- Borderline resectable periampullary cancer (requiring duodenopancreatectomy) (NCCN guidelines 2020)
- Age >18 years
- Written patient consent
Who cannot join
- Contraindication for a radical resection procedure
- Unresectable tumor (NCCN guidelines 2020) or metastatic disease (lgll station 16 not included)
- Mental or organic disorders which could interfere with giving informed consent or receiving treatments
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
Sweden5 sites, 2 recruiting
- Active, not recruiting
Sahlgrenska university hospital
Gothenburg
- Active, not recruiting
Linköping University Hospital
Linköping
- Active, not recruiting
Skåne University Hospital
Lund
- Recruiting
Norrland University Hospital
Umeå
Oskar Franklin
- Recruiting
Uppsala University Hospital
Uppsala, 75653
Jon Unosson, 0186110000, jon.unosson@uu.se
Denmark1 site, 1 recruiting
- Not yet recruiting
Odense University Hospital
Odense
Michael Bau Mortensen
About this study
Official title: Prevalence and Consequences of Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer: a Prospective Population Based Multicenter Study. The PALN Study
Lymph node metastases are a strong prognostic predictor for pancreatic cancer. Para-aortic lymph nodes (PALN) are the final nodes for periampullary cancers before the cancer cells enter the systemic lymphatic circulation. Some consider these nodes to be regional lymph nodes and dissect them as a part of a routine lymphadenectomy for pancreatic cancer. Others argue that metastases to these nodes represent systemic disease and recommend that radical surgery including extended lymphadenectomy should be abandoned.
The aim of this study is to define the incidence and clinical consequences of PALN metastasis in patients submitted to a tentative curative resection for carcinoma of the head of the pancreas by systematically resecting paraaortic lymph nodes.
Read more
Primary outcome
- To determine incidence of PALN metastasis in patients submitted to a tentative curative resection
Secondary outcomes
- To determine prognosis of patients with PALN metastasis after a curative resection
- To determine incidence of metastasis in reginal lymph nodes in patients submitted to a tentative curative resection.
- To determine prognosis of patients with metastasis in regional lymph nodes in patients submitted to a tentative curative resection.
- To address the question of how to optimize the frozen section analyses of PALN as related to the final pathology report.
300 patients are planned to be included in the trial.
Read the detailed description
Lymph node metastases are a strong prognostic predictor for pancreatic cancer. Para-aortic lymph nodes (PALN) (No. 16 nodes) are the final nodes for periampullary cancers before the cancer cells enter the systemic lymphatic circulation. Some consider these nodes to be regional lymph nodes and dissect them as a part of a routine lymphadenectomy for pancreatic cancer. Others argue that metastases to these nodes represent systemic disease and recommend that radical surgery including extended lymphadenectomy should be abandoned. There is no consensus whether to abort the resection if metastases in PALN are discovered pre- or perioperatively. Use of adjuvant and neoadjuvant chemotherapy may further affect the impact of lymph node metastases, including PALN.
The aim of this study is to define the incidence and clinical consequences of PALN metastasis in patients submitted to a tentative curative resection for carcinoma of the head of the pancreas by systematically resecting paraaortic lymph nodes.
Primary outcome
- To determine incidence of PALN metastasis in patients submitted to a tentative curative resection
Secondary outcomes
- To determine prognosis of patients with PALN metastasis after a curative resection
- To determine incidence of metastasis in reginal lymph nodes in patients submitted to a tentative curative resection.
- To determine prognosis of patients with metastasis in regional lymph nodes in patients submitted to a tentative curative resection.
- To address the question of how to optimize the frozen section analyses of PALN as related to the final pathology report.
PALN are resected separately and analyzed both as cryo sections and by routine histochemistry.
Prevalence of PALN differ markedly from 5% to 30%. Given the descriptive primary endpoint, no rigorous power calculation can be made. Assuming a prevalence of 17% (as reported in a recent series from Stockholm), a hazard ratio for survival ranging from 1,04 to 3,00 and and a drop out of 17%. Complete data is needed for 90 patients but the trial aim to include 300.
Resection of PALN is becoming routine at most participating centers in the trial. Therefore, the trial will not alter care for the participating patients in any major way. Rather the trial aims to systematically asses how this altered practice affect patient outcome.
- Being tested
- PALN resection
- Medical subject headings
- Pancreatic Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PALN resectionProcedure or surgery
Resection of paraaortic lymph nodes in pancreatic cancer
| Study group | Role | What they receive |
|---|---|---|
| Resection of Paraartic lymph nodes | Other | Single arm Receives: Procedure: PALN resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of paraaortic lymph nodes in pancreatic cancer in patients submitted to a tentative curative resection
Frequency of metastases in paraaortic lymph nodes in patients with resectable pancreatic cancer will be assessed by systematically resecting these glands, irrespective of perioperative findings.
Measured: 5 years
Secondary outcomes (4)
To determine prognosis of patients with PALN metastasis (lgll station 16) after a curative resection
Overall survival in years from resection will be measured in patients with and without PALN metastasis
Measured: 6 years
To determine incidence of metastasis in lgll station 8, 9 and 12 in patients submitted to a tentative curative resection.
Frequency of metastases in lymph node 8, 9 and 12 in patients with resectable pancreatic cancer will be assessed by systematically resecting these glands and placing them i separate vials as opposed to en-bloc with the main specimen in order to determine rate of lymph node metastases.
Measured: 5 years
To determine prognosis of patients with metastasis in lgll station 8, 9 and 12 in patients submitted to a tentative curative resection.
Overall survival in years from resection will be measured in patients with and without metastases in lymph node stations 8, 9 and 12.
Measured: 6 years
To address the question of how to optimize the frozen section analyses (lgll station 16) as related to the final pathology report?
Overall survival in years from resection will be measured in patients with and without metastasis in PALN detected on cryosection
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start5 Sep 2023
- Primary completion5 Sep 2026 (estimated)
- Study completion5 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jon Unosson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jon Unosson, Uppsala University Hospital
- Investigators
- Britt-Marie Karlson, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065891
- Sponsor's protocol ID
- PALN
- Acronym
- PALN
- Status last verified
- Sep 2023
- First submitted
- 8 Sep 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: May be available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Consequences of Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer: a Prospective Population Based Multicenter Study. The PALN Study
- ClinicalTrials.gov ID
- NCT06065891
- Acronym / sponsor ID
- PALN / PALN
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Jon UnossonUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 5 Sep 2026 (estimated)
- Study completion
- 5 Sep 2028 (estimated)
- First posted
- 4 Oct 2023 (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.
Lymph node metastases are a strong prognostic predictor for pancreatic cancer. Para-aortic lymph nodes (PALN) are the final nodes for periampullary cancers before the cancer cells enter the systemic lymphatic circulation. Some consider these nodes to be regional lymph nodes and dissect them as a part of a routine lymphadenectomy for pancreatic cancer. Others argue that metastases to these nodes represent systemic disease and recommend that radical surgery including extended lymphadenectomy should be abandoned.
The aim of this study is to define the incidence and clinical consequences of PALN metastasis in patients submitted to a tentative curative resection for carcinoma of the head of the pancreas by systematically resecting paraaortic lymph nodes.
Primary outcome
- To determine incidence of PALN metastasis in patients submitted to a tentative curative resection
Secondary outcomes
- To determine prognosis of patients with PALN metastasis after a curative resection
- To determine incidence of metastasis in reginal lymph nodes in patients submitted to a tentative curative resection.
- To determine prognosis of patients with metastasis in regional lymph nodes in patients submitted to a tentative curative resection.
- To address the question of how to optimize the frozen section analyses of PALN as related to the final pathology report.
300 patients are planned to be included in the trial.
Detailed description
Lymph node metastases are a strong prognostic predictor for pancreatic cancer. Para-aortic lymph nodes (PALN) (No. 16 nodes) are the final nodes for periampullary cancers before the cancer cells enter the systemic lymphatic circulation. Some consider these nodes to be regional lymph nodes and dissect them as a part of a routine lymphadenectomy for pancreatic cancer. Others argue that metastases to these nodes represent systemic disease and recommend that radical surgery including extended lymphadenectomy should be abandoned. There is no consensus whether to abort the resection if metastases in PALN are discovered pre- or perioperatively. Use of adjuvant and neoadjuvant chemotherapy may further affect the impact of lymph node metastases, including PALN.
The aim of this study is to define the incidence and clinical consequences of PALN metastasis in patients submitted to a tentative curative resection for carcinoma of the head of the pancreas by systematically resecting paraaortic lymph nodes.
Primary outcome
- To determine incidence of PALN metastasis in patients submitted to a tentative curative resection
Secondary outcomes
- To determine prognosis of patients with PALN metastasis after a curative resection
- To determine incidence of metastasis in reginal lymph nodes in patients submitted to a tentative curative resection.
- To determine prognosis of patients with metastasis in regional lymph nodes in patients submitted to a tentative curative resection.
- To address the question of how to optimize the frozen section analyses of PALN as related to the final pathology report.
PALN are resected separately and analyzed both as cryo sections and by routine histochemistry.
Prevalence of PALN differ markedly from 5% to 30%. Given the descriptive primary endpoint, no rigorous power calculation can be made. Assuming a prevalence of 17% (as reported in a recent series from Stockholm), a hazard ratio for survival ranging from 1,04 to 3,00 and and a drop out of 17%. Complete data is needed for 90 patients but the trial aim to include 300.
Resection of PALN is becoming routine at most participating centers in the trial. Therefore, the trial will not alter care for the participating patients in any major way. Rather the trial aims to systematically asses how this altered practice affect patient outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resection of Paraartic lymph nodes | Other | Procedure: PALN resectionSingle arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Resectable suspected periampullary cancer (requiring duodenopancreatectomy) (NCCN guidelines 2020)
- Borderline resectable periampullary cancer (requiring duodenopancreatectomy) (NCCN guidelines 2020)
- Age >18 years
- Written patient consent
Key exclusion criteria (3 listed)
- Contraindication for a radical resection procedure
- Unresectable tumor (NCCN guidelines 2020) or metastatic disease (lgll station 16 not included)
- Mental or organic disorders which could interfere with giving informed consent or receiving treatments
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 |
|---|---|---|
| PALN resectionResection of paraaortic lymph nodes in pancreatic cancer | Procedure or surgery | Resection of Paraartic lymph nodes |
Primary outcome
Prevalence of paraaortic lymph nodes in pancreatic cancer in patients submitted to a tentative curative resection
Time frame: 5 years
Frequency of metastases in paraaortic lymph nodes in patients with resectable pancreatic cancer will be assessed by systematically resecting these glands, irrespective of perioperative findings.
4 secondary outcomes
To determine prognosis of patients with PALN metastasis (lgll station 16) after a curative resection
Time frame: 6 years
To determine incidence of metastasis in lgll station 8, 9 and 12 in patients submitted to a tentative curative resection.
Time frame: 5 years
To determine prognosis of patients with metastasis in lgll station 8, 9 and 12 in patients submitted to a tentative curative resection.
Time frame: 6 years
To address the question of how to optimize the frozen section analyses (lgll station 16) as related to the final pathology report?
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: No. May be available upon reasonable request
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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.
Britt-Marie Karlson principal investigator
Uppsala University Hospital
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PALN resection in people with Pancreas Cancer and Pancreas Adenocarcinoma, run by Jon Unosson at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden, Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Månsson (0186110000, Christopher.mansson@akademiska.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of paraaortic lymph nodes in pancreatic cancer in patients submitted to a tentative curative resection (time frame: 5 years). 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 4 Oct 2023.