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Para-aortic Lymphnodes Removal During Upfront Pancreaticoduodenectomy

RecruitingNAAges 18 Years - anyAllHumanitas Hospital, Italy
NCT04571294 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 pros

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📋 Eligibility rules (as published)
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.
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What it tests

  • removal of para-aortic lymphnodes (PALN)
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Where

1 site
Humanitas Research Hospital
Rozzano, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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