RecruitingNot ApplicableNCT04571294

Para-aortic Lymphnodes Removal During Upfront Pancreaticoduodenectomy

Para-aortic Lymphnodes Removal During Upfront Pancreaticoduodenectomy for Pancreatic Ductal Adenocarcinoa: Should it be Performed? A Multicentre Randomized Controlled Trial.


Sponsor

Humanitas Hospital, Italy

Enrollment

180 participants

Start Date

May 26, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria4

  • PD performed after neoadjuvant treatment;
  • PALN metastases diagnosed by a pre-operative PET-FDG (if performed);
  • intraoperative distant metastases;
  • R2 resection.

Interventions

PROCEDUREremoval of para-aortic lymphnodes (PALN)

During pancreaticoduodenectomy, para-aortic lymphnodes (PALN) will be removed for the surgeon


Locations(1)

Humanitas Research Hospital

Rozzano, Italy/Milan, Italy

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NCT04571294


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