Investigating lymph node metastasis in pancreatic cancer surgery
Prevalence and Consequences of Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer: a Prospective Population Based Multicenter Study. The PALN Study
This study is testing whether removing certain lymph nodes during pancreatic cancer surgery can help doctors understand how the cancer spreads and improve treatment for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Uppsala University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 6 sites (Odense and 5 other locations) |
| Trial ID | NCT06065891 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the incidence and clinical implications of para-aortic lymph node (PALN) metastasis in patients undergoing curative resection for pancreatic cancer. By systematically resecting PALNs during surgery, the study seeks to clarify whether these nodes should be considered regional or indicative of systemic disease. The primary outcome focuses on determining the incidence of PALN metastasis, while secondary outcomes include evaluating the prognosis of patients with such metastasis and the incidence of metastasis in regional lymph nodes. The findings could influence surgical approaches and treatment strategies for pancreatic cancer.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with resectable or borderline resectable periampullary cancer requiring duodenopancreatectomy.
Not a fit: Patients with unresectable tumors or those with contraindications for radical resection will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical strategies and better prognostic understanding for patients with pancreatic cancer.
How similar studies have performed: While there is ongoing debate regarding the management of PALN metastasis, this study's systematic approach to resection is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Resectable suspected periampullary cancer (requiring duodenopancreatectomy) (NCCN guidelines 2020) Borderline resectable periampullary cancer (requiring duodenopancreatectomy) (NCCN guidelines 2020) Age \>18 years Written patient consent Exclusion Criteria: 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
Where this trial is running
Odense and 5 other locations
- 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, Sweden (Recruiting)
Study contacts
- Principal investigator: Britt-Marie Karlson — Uppsala University Hospital
- Study coordinator: Christopher Månsson
- Email: Christopher.mansson@akademiska.se
- Phone: 0186110000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.