Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer

Recruiting now · Not applicable

Conditions studied: Pancreas Cancer, Pancreas Adenocarcinoma, Lymph Node Metastasis

In brief

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.

Key facts

Study ID

NCT06065891

Run by

Jon Unosson

People needed

300

Starts

2023-09-05

Expected to finish

2028-09-05

Last updated by the study team

2023-10-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Resectable suspected periampullary cancer (requiring duodenopancreatectomy) (NCCN guidelines 2020)
• Borderline resectable periampullary cancer (requiring duodenopancreatectomy) (NCCN guidelines 2020)
• Age >18 years
• Written patient consent

You may not qualify if…

• 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

Where it is running

• Norrland University Hospital — Umeå, Sweden (enrolling)
• Uppsala University Hospital — Uppsala, Sweden (enrolling)
• Odense University Hospital — Odense, Denmark
• Sahlgrenska university hospital — Gothenburg, Sweden
• Linköping University Hospital — Linköping, Sweden
• Skåne University Hospital — Lund, Sweden

Full record on ClinicalTrials.gov

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