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

Plain Language Summary

Simplified for easier understanding

This surgical study examines whether removing lymph nodes near the large abdominal blood vessels (called para-aortic lymph nodes) during surgery for pancreatic head cancer improves survival outcomes. Researchers are comparing standard lymph node removal to extended removal of these additional nodes. **You may be eligible if...** - You have been diagnosed with cancer in the head of the pancreas (pancreatic ductal adenocarcinoma, or PDAC), confirmed before or during surgery - You are scheduled for a specific surgery called a pancreaticoduodenectomy (Whipple procedure) - No neoadjuvant (pre-surgery) chemotherapy has been given **You may NOT be eligible if...** - You have already received chemotherapy or radiation before surgery - A pre-operative PET scan showed cancer had spread to the para-aortic lymph nodes - Cancer is found to have spread to other organs during surgery - The surgery cannot remove all visible cancer (incomplete resection) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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