Removal of para-aortic lymph nodes during pancreatic surgery
Para-aortic Lymphnodes Removal During Upfront Pancreaticoduodenectomy for Pancreatic Ductal Adenocarcinoa: Should it be Performed? A Multicentre Randomized Controlled Trial.
This study is testing whether removing para-aortic lymph nodes during surgery for pancreatic cancer can improve survival and slow down disease progression for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Humanitas Hospital, Italy Academic / other |
| Locations | 1 site (Rozzano, Italy/Milan) |
| Trial ID | NCT04571294 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of removing para-aortic lymph nodes during pancreaticoduodenectomy for patients diagnosed with pancreatic ductal adenocarcinoma (PDAC). The study aims to clarify the role of para-aortic lymphadenectomy, which remains debated in the context of standard lymphadenectomy practices. Participants will undergo surgery to remove the pancreatic head along with the standard lymph nodes, with a focus on assessing the potential benefits of including para-aortic lymph nodes in the procedure. The trial will evaluate outcomes based on survival and disease progression.
Who should consider this trial
Good fit: Ideal candidates are patients with a pre-operative diagnosis of pancreatic head PDAC who are scheduled for upfront pancreaticoduodenectomy with standard lymphadenectomy.
Not a fit: Patients who have undergone neoadjuvant treatment or have confirmed para-aortic lymph node metastases will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve survival rates and prognostic outcomes for patients with pancreatic cancer.
How similar studies have performed: Previous studies have shown no survival benefit from extended lymphadenectomy, making this investigation a novel approach to refining surgical techniques in pancreatic cancer treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * pre-operative radiological or histological diagnosis of pancreatic head PDAC, including PDAC arising from IPMN (invasive-IPMN) (in case of not confirmation of PDAC at final pathological examination, the case will be considered as a "drop out" and excluded from the study); * upfront PD associated with standard lymphadenectomy. Exclusion Criteria: * PD performed after neoadjuvant treatment; * PALN metastases diagnosed by a pre-operative PET-FDG (if performed); * intraoperative distant metastases; * R2 resection.
Where this trial is running
Rozzano, Italy/Milan
- Humanitas Research Hospital — Rozzano, Italy/Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Gennaro Nappo, MD
- Email: gennaro.nappo@humanitas.it
- Phone: 00393471926757
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.