Prevalence and Consequences of Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer: a Prospective Population Based Multicenter Study. The PALN Study

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Resectable suspected periampullary cancer (requiring duodenopancreatectomy) (NCCN guidelines 2020)

• Borderline resectable periampullary cancer (requiring duodenopancreatectomy) (NCCN guidelines 2020)

• Age \>18 years

• Written patient consent

Locations
Other Locations
Denmark
Odense University Hospital
NOT_YET_RECRUITING
Odense
Sweden
Sahlgrenska university hospital
ACTIVE_NOT_RECRUITING
Gothenburg
Linköping University Hospital
ACTIVE_NOT_RECRUITING
Linköping
Skåne University Hospital
ACTIVE_NOT_RECRUITING
Lund
Norrland University Hospital
RECRUITING
Umeå
Uppsala University Hospital
RECRUITING
Uppsala
Contact Information
Primary
Christopher Månsson
Christopher.mansson@akademiska.se
0186110000
Backup
Britt-Marie Karlson
britt-marie.karlson@akademiska.se
0186110000
Time Frame
Start Date: 2023-09-05
Estimated Completion Date: 2028-09-05
Participants
Target number of participants: 300
Treatments
Other: Resection of Paraartic lymph nodes
Single arm
Related Therapeutic Areas
Sponsors
Leads: Jon Unosson

This content was sourced from clinicaltrials.gov

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