Actively Recruiting
Para-aortic Lymphnodes Removal During Upfront Pancreaticoduodenectomy
Led by Humanitas Hospital, Italy · Updated on 2024-10-04
180
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Pancreaticoduodenectomy (PD) associated with lymphadenectomy is the only curative option for patients affected by pancreatic ductal adenocarcinoma (PDAC). In 2014, the International Study Group on Pancreatic Surgery (ISGPS) defined the "standard lymphadenectomy", that is mandatory during PD for PDAC. Lymphadenectomy should include the removal of the hepatoduodenal ligament nodes (stations 5, 6, 12b1, 12b2, 12c according the classification of Japanese Pancreas Society), nodes along the hepatic artery (station 8a), the posterior surface of the pancreatic head (station 13a and 13b), the superior mesenteric artery (14a right lateral side, 14b right lateral side) and nodes of the anterior surface of the pancreatic head (stations 17a and 17b). The inclusion of para-aortic lymphnodes (PALN) (station 16) in standard lymphadenectomy is still matter of debate. Moreover, some retrospectives or prospective studies reported that the presence of PALN metastases has a significant negative prognostic impact. Until now, no randomized studies comparing PD associated with standard lymphadenectomy with or without removal of PALN have been published. The aim of this study is to evaluate if the removal of station 16 should be routinely included in standard lymphadenectomy during PD for PDAC.
CONDITIONS
Official Title
Para-aortic Lymphnodes Removal During Upfront Pancreaticoduodenectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pre-operative radiological or histological diagnosis of pancreatic head PDAC, including invasive-IPMN arising PDAC
- Planned upfront pancreaticoduodenectomy with standard lymphadenectomy
You will not qualify if you...
- Pancreaticoduodenectomy performed after neoadjuvant treatment
- Para-aortic lymph node metastases diagnosed by pre-operative PET-FDG (if performed)
- Presence of intraoperative distant metastases
- R2 resection (incomplete tumor removal with microscopic residual tumor tissue)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Humanitas Research Hospital
Rozzano, Italy/Milan, Italy, 20089
Actively Recruiting
Research Team
G
Gennaro Nappo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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