Para-aortic Lymphnodes Removal During Upfront Pancreaticoduodenectomy
Recruiting now · Not applicable
Conditions studied: Pancreas Cancer, Pancreaticoduodenal Lymphadenopathy, Pancreas Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT04571294
- Run by
- Humanitas Hospital, Italy
- People needed
- 180
- Starts
- 2020-05-26
- Expected to finish
- 2025-05-31
- Last updated by the study team
- 2024-10-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- PD performed after neoadjuvant treatment;
- PALN metastases diagnosed by a pre-operative PET-FDG (if performed);
- intraoperative distant metastases;
- R2 resection.
Where it is running
- Humanitas Research Hospital — Rozzano, Italy/Milan, Italy (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.