Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06065891

Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer

Led by Jon Unosson · Updated on 2023-10-04

300

Participants Needed

6

Research Sites

261 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Resectable suspected periampullary cancer requiring duodenopancreatectomy according to NCCN 2020 guidelines
  • Borderline resectable periampullary cancer requiring duodenopancreatectomy according to NCCN 2020 guidelines
  • Age over 18 years
  • Written patient consent
Not Eligible

You will not qualify if you...

  • Contraindication for a radical resection procedure
  • Unresectable tumor or metastatic disease according to NCCN 2020 guidelines
  • Mental or organic disorders interfering with informed consent or treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Odense University Hospital

Odense, Denmark

Not Yet Recruiting

2

Sahlgrenska university hospital

Gothenburg, Sweden

Active, Not Recruiting

3

Linköping University Hospital

Linköping, Sweden

Active, Not Recruiting

4

Skåne University Hospital

Lund, Sweden

Active, Not Recruiting

5

Norrland University Hospital

Umeå, Sweden

Actively Recruiting

6

Uppsala University Hospital

Uppsala, Sweden, 75653

Actively Recruiting

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Research Team

C

Christopher Månsson

CONTACT

B

Britt-Marie Karlson

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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