Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer (PALN)

September 26, 2023 updated by: Jon Unosson

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.

Primary outcome

1) To determine incidence of PALN metastasis in patients submitted to a tentative curative resection

Secondary outcomes

  1. To determine prognosis of patients with PALN metastasis after a curative resection
  2. To determine incidence of metastasis in reginal lymph nodes in patients submitted to a tentative curative resection.
  3. To determine prognosis of patients with metastasis in regional lymph nodes in patients submitted to a tentative curative resection.
  4. 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

1) To determine incidence of PALN metastasis in patients submitted to a tentative curative resection

Secondary outcomes

  1. To determine prognosis of patients with PALN metastasis after a curative resection
  2. To determine incidence of metastasis in reginal lymph nodes in patients submitted to a tentative curative resection.
  3. To determine prognosis of patients with metastasis in regional lymph nodes in patients submitted to a tentative curative resection.
  4. 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 Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Odense, Denmark
        • Not yet recruiting
        • Odense University Hospital
        • Contact:
          • Michael Bau Mortensen
  • Sweden
      • Göteborg, Sweden
        • Active, not recruiting
        • Sahlgrenska University Hospital
      • Linköping, Sweden
        • Active, not recruiting
        • Linköping University Hospital
      • Lund, Sweden
        • Active, not recruiting
        • Skane University Hospital
      • Umeå, Sweden
        • Recruiting
        • Norrland University Hospital
        • Contact:
          • Oskar Franklin
      • Uppsala, Sweden, 75653
        • Recruiting
        • Uppsala University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Resectable suspected periampullary cancer (requiring duodenopancreatectomy) (NCCN guidelines 2020)

Borderline resectable periampullary cancer (requiring duodenopancreatectomy) (NCCN guidelines 2020)

Age >18 years

Written patient consent

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Resection of Paraartic lymph nodes
Single arm
Procedure: PALN resection
Resection of paraaortic lymph nodes in pancreatic cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine prognosis of patients with PALN metastasis (lgll station 16) after a curative resection
Time Frame: 6 years
Overall survival in years from resection will be measured in patients with and without PALN metastasis
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
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.
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
Overall survival in years from resection will be measured in patients with and without metastases in lymph node stations 8, 9 and 12.
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
Overall survival in years from resection will be measured in patients with and without metastasis in PALN detected on cryosection
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jon Unosson

Investigators

  • Principal Investigator: Britt-Marie Karlson, Uppsala University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2023

Primary Completion (Estimated)

September 5, 2026

Study Completion (Estimated)

September 5, 2028

Study Registration Dates

First Submitted

September 8, 2023

First Submitted That Met QC Criteria

September 26, 2023

First Posted (Actual)

October 4, 2023

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PALN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

May be available upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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