Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer

NCT06065891 | Recruiting

• 1 other identifier: PALN
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 6

Brief 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. 1.To determine prognosis of patients with PALN metastasis after a curative resection
2. 2.To determine incidence of metastasis in reginal lymph nodes in patients submitted to a tentative curative resection.
3. 3.To determine prognosis of patients with metastasis in regional lymph nodes in patients submitted to a tentative curative resection.
4. 4.To address the question of how to optimize the frozen section analyses of PALN as related to the final pathology report.

Conditions

Pancreas Cancer; Pancreas Adenocarcinoma; Lymph Node Metastasis

Outcome Measures

Primary Outcomes (1)

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

  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.

  5 years

Secondary Outcomes (4)

• To determine prognosis of patients with PALN metastasis (lgll station 16) after a curative resection

  6 years

• To determine incidence of metastasis in lgll station 8, 9 and 12 in patients submitted to a tentative curative resection.

  5 years

• To determine prognosis of patients with metastasis in lgll station 8, 9 and 12 in patients submitted to a tentative curative resection.

  6 years

• To address the question of how to optimize the frozen section analyses (lgll station 16) as related to the final pathology report?

  5 years

Study Arms (1)

Resection of Paraartic lymph nodes

OTHER

Single arm

Procedure: PALN resection

Interventions

PALN resection PROCEDURE

Resection of paraaortic lymph nodes in pancreatic cancer

Resection of Paraartic lymph nodes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jon Unosson: lead

Study Sites (6)

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, 75653, Sweden

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Britt-Marie Karlson

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Månsson

CONTACT

0186110000; Christopher.mansson@akademiska.se

Britt-Marie Karlson

CONTACT

0186110000; britt-marie.karlson@akademiska.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: October 4, 2023
• Study Start: September 5, 2023
• Primary Completion (Estimated): September 5, 2026
• Study Completion (Estimated): September 5, 2028
• Last Updated: October 4, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (5); DK (1)