NCT04571294 Para-aortic Lymphnodes Removal During Upfront Pancreaticoduodenectomy
| NCT ID | NCT04571294 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Humanitas Hospital, Italy |
| Condition | Pancreas Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2020-05-26 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2020-05-26 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04571294 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreas Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04571294 currently recruiting?
Yes, NCT04571294 is actively recruiting participants. Contact the research team at gennaro.nappo@humanitas.it for enrollment information.
Where is the NCT04571294 trial being conducted?
This trial is being conducted at Rozzano, Italy.
Who is sponsoring the NCT04571294 clinical trial?
NCT04571294 is sponsored by Humanitas Hospital, Italy. The trial plans to enroll 180 participants.
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