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RECRUITING
NCT04571294
NA

Para-aortic Lymphnodes Removal During Upfront Pancreaticoduodenectomy

Sponsor: Humanitas Hospital, Italy

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2020-05-26

Completion Date

2025-05-31

Last Updated

2024-10-04

Healthy Volunteers

No

Interventions

PROCEDURE

removal 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