Trial0

Clinical trial · NCT06065891 · RECRUITING · NA

Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer

Sponsor: Jon Unosson

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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.

Interventions

  • PALN resection · PROCEDURE

    Resection of paraaortic lymph nodes in pancreatic cancer

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (6)

  • Odense University Hospital, Odense, Denmark · NOT_YET_RECRUITING
  • Sahlgrenska university hospital, Gothenburg, Sweden · ACTIVE_NOT_RECRUITING
  • Linköping University Hospital, Linköping, Sweden · ACTIVE_NOT_RECRUITING
  • Skåne University Hospital, Lund, Sweden · ACTIVE_NOT_RECRUITING
  • Norrland University Hospital, Umeå, Sweden · RECRUITING
  • Uppsala University Hospital, Uppsala, Sweden · RECRUITING

Not medical advice. Trial0 is a navigation service, not a medical provider. Nothing here is medical advice or a recommendation to pursue any treatment; eligibility matching is informational, based on published registry criteria, and only the trial site or treating clinician can determine actual eligibility. Decisions belong with the patient and their own doctors. Registry data refreshed at most hourly; last update posted 2023-10-04.