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Recruiting Not applicable

Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer

NCT06065891 · tracked via the Priya Life Science Sweden tracker
Sponsor
Jon Unosson
Phase
Not applicable
Started
2023-09-05
Last updated
2023-10-04

Condition(s) studied

Pancreas CancerPancreas AdenocarcinomaLymph Node Metastasis

Investigational drug(s) / intervention(s)

PALN resection

PALN resection: Resection of paraaortic lymph nodes in pancreatic cancer

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Prevalence of paraaortic lymph nodes in pancreatic cancer in patients submitted to a tentative curative resection — 5 years
    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.

Trial sites (6)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06065891 on ClinicalTrials.gov ↗ ← All trials in Sweden