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Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer

ConditionsPancreas CancerPancreas AdenocarcinomaLymph Node Metastasis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJon Unosson

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • PALN resection

    Procedure/Surgery

    Resection of paraaortic lymph nodes in pancreatic cancer

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Resection of Paraartic lymph nodesOther 1 intervention

Trial outcomes

Primary outcomes

1

Prevalence of paraaortic lymph nodes in pancreatic cancer in patients submitted to a tentative curative resection

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.

Time frame
5 years

Secondary outcomes

1

To determine prognosis of patients with PALN metastasis (lgll station 16) after a curative resection

Overall survival in years from resection will be measured in patients with and without PALN metastasis

Time frame
6 years
2

To determine incidence of metastasis in lgll station 8, 9 and 12 in patients submitted to a tentative curative resection.

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.

Time frame
5 years
3

To determine prognosis of patients with metastasis in lgll station 8, 9 and 12 in patients submitted to a tentative curative resection.

Overall survival in years from resection will be measured in patients with and without metastases in lymph node stations 8, 9 and 12.

Time frame
6 years
4

To address the question of how to optimize the frozen section analyses (lgll station 16) as related to the final pathology report?

Overall survival in years from resection will be measured in patients with and without metastasis in PALN detected on cryosection

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jon Unosson

Lead sponsor

Uppsala University Hospital

Sponsor institution

Source ClinicalTrials.gov
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