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NCT06065891Recruiting

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

Source: ClinicalTrials.gov · Last updated 4 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
300 (estimated)
First submitted
8 Sept 2023
Start date
5 Sept 2023
Primary completion date
5 Sept 2026
Lead sponsor
Jon Unosson
NCT number
NCT06065891

What you commit to

  • Study type: Interventional
  • Planned participants: 300
  • From 5 Sept 2023 to the primary completion date, 5 Sept 2026
  • 6 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Contraindication for a radical resection procedure
  • Mental or organic disorders which could interfere with giving informed consent or receiving treatments

Other illness

  • Unresectable tumor (NCCN guidelines 2020) or metastatic disease (lgll station 16 not included)

Who the study is looking for

  • Resectable suspected periampullary cancer (requiring duodenopancreatectomy) (NCCN guidelines 2020)
  • Borderline resectable periampullary cancer (requiring duodenopancreatectomy) (NCCN guidelines 2020)
  • Age \>18 years
  • Written patient consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Odense University Hospital
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OdenseDenmarkNot yet recruiting
Sahlgrenska University Hospital
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GothenburgSwedenActive, not recruiting
Linkoping University Hospital
Coordinator of this site? Confirm its status
LinköpingSwedenActive, not recruiting
Skåne University Hospital
Coordinator of this site? Confirm its status
LundSwedenActive, not recruiting
Norrland University Hospital
Coordinator of this site? Confirm its status
UmeåSwedenRecruiting
Uppsala University Hospital
Coordinator of this site? Confirm its status
UppsalaSwedenRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.