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

Plain Language Summary

Simplified for easier understanding

This study investigates whether lymph nodes near the main abdominal artery (called para-aortic lymph nodes) should be removed during surgery for pancreatic cancer located near the area where the stomach, liver, and pancreas connect (periampullary region). The goal is to understand if removing these nodes improves survival. **You may be eligible if...** - You are over 18 years old - You have suspected periampullary cancer (cancer near the junction of the bile duct, pancreatic duct, and small intestine) - Your cancer is considered resectable (removable by surgery) or borderline resectable, requiring a procedure called duodenopancreatectomy (Whipple procedure) - You can give written consent **You may NOT be eligible if...** - Your cancer has spread to distant areas (metastatic) - You have a contraindication to major surgery - Mental or medical conditions prevent you from providing informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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NCT06065891


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