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Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer

NCT06065891 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-10-04

No results posted yet for this 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.

Conditions

  • Pancreas Cancer
  • Pancreas Adenocarcinoma
  • Lymph Node Metastasis

Interventions

PROCEDURE

PALN resection

Resection of paraaortic lymph nodes in pancreatic cancer

Sponsors & Collaborators

  • Jon Unosson

    lead OTHER

Principal Investigators

  • Britt-Marie Karlson · Uppsala University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-05
Primary Completion
2026-09-05
Completion
2028-09-05

Countries

  • Denmark
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06065891 on ClinicalTrials.gov