Examining lymph node spread patterns after surgery for pancreatic cancer
A Prospective Lymphadenectomy Protocol to Investigate the Pattern of Nodal Spread and Its Association With Oncologic Outcomes in Post-neoadjuvant Pancreatoduodenectomy
This study looks at how pancreatic cancer spreads to lymph nodes after surgery to see if changes from treatment affect the best surgical methods for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 850 (estimated) |
| Sex | All |
| Sponsor | Universita di Verona Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Verona, VR) |
| Trial ID | NCT06135649 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the patterns of lymph node spread in patients who have undergone pancreatoduodenectomy following neoadjuvant chemotherapy for localized pancreatic ductal adenocarcinoma. It aims to address the ongoing debate regarding the effectiveness of lymphadenectomy in this context, particularly in light of therapy-induced changes in lymph node characteristics. By analyzing detailed data on lymph node dissection protocols and the spatial location of metastases, the study seeks to provide insights that could refine surgical approaches and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients who have undergone post-neoadjuvant pancreatoduodenectomy for localized pancreatic ductal adenocarcinoma.
Not a fit: Patients with oligometastatic disease, those who had upfront pancreatectomy, or those with incomplete lymphadenectomy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance surgical strategies and improve prognostic accuracy for patients with pancreatic cancer.
How similar studies have performed: While there is ongoing debate in this area, previous studies have primarily relied on retrospective data, making this approach novel in its focus on detailed lymph node dissection analysis post-neoadjuvant treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Post-neoadjuvant pancreatoduodenectomy for localized pancreatic ductal adenocarcinoma. Exclusion Criteria: * Oligometastatic disease * Upfront pancreatectomy * Incomplete lymphadenectomy * Macroscopically incomplete resections * Rare variants of pancreatic cancer
Where this trial is running
Verona, VR
- Unit of Pancreatic Surgery - G.B. Rossi Hospital, University of Verona Hospital Trust — Verona, Vr, Italy (Recruiting)
Study contacts
- Study coordinator: Giuseppe Malleo, MD PhD
- Email: giuseppe.malleo@aovr.veneto.it
- Phone: 00390458126008
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.