RecruitingNot ApplicableNCT06065891

Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer

Prevalence and Consequences of Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer: a Prospective Population Based Multicenter Study. The PALN Study


Sponsor

Jon Unosson

Enrollment

300 participants

Start Date

Sep 5, 2023

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria3

  • 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

Interventions

PROCEDUREPALN resection

Resection of paraaortic lymph nodes in pancreatic cancer


Locations(6)

Odense University Hospital

Odense, Denmark

Sahlgrenska university hospital

Gothenburg, Sweden

Linköping University Hospital

Linköping, Sweden

Skåne University Hospital

Lund, Sweden

Norrland University Hospital

Umeå, Sweden

Uppsala University Hospital

Uppsala, Sweden

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06065891


Related Trials