About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
PD performed after neoadjuvant treatment;
PALN metastases diagnosed by a pre-operative PET-FDG (if performed);
intraoperative distant metastases;
R2 resection.
Trial design
Parallel
Treatments tested in this trial
removal of para-aortic lymphnodes (PALN)
Procedure/SurgeryDuring pancreaticoduodenectomy, para-aortic lymphnodes (PALN) will be removed for the surgeon
Treatment groups
Trial outcomes
Primary outcomes
Overall Survival (OS)
The primary endpoint is to compare overall survival (OS) in patients with (group A) and without (group B) removal of PALN
Secondary outcomes
PALN metastases
to evaluate the rate of PALN metastases (for group A, only)
DFS in case of PALN metastases
to evaluate the prognostic impact, in terms of Disease Free Survival (DFS), of PALN metastases (for group A, only)
OS in case of PALN metastases
to evaluate the prognostic impact, in terms of OS, of PALN metastases (for group A, only)
predictive factors of PALN metastases
to evaluate possible pre- and intra-operative predictive factors of PALN metastases (for group A, only)
Sponsors and contacts
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