Para-aortic Lymphnodes Removal During Upfront Pancreaticoduodenectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHumanitas Hospital, Italy

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

PD performed after neoadjuvant treatment;

PALN metastases diagnosed by a pre-operative PET-FDG (if performed);

intraoperative distant metastases;

R2 resection.

Trial design

Design model

Parallel

Treatments tested in this trial

  • removal of para-aortic lymphnodes (PALN)

    Procedure/Surgery

    During pancreaticoduodenectomy, para-aortic lymphnodes (PALN) will be removed for the surgeon

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: group AExperimental treatment 1 intervention
Group B: group BNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

The primary endpoint is to compare overall survival (OS) in patients with (group A) and without (group B) removal of PALN

Time frame
48 months

Secondary outcomes

1

PALN metastases

to evaluate the rate of PALN metastases (for group A, only)

Time frame
12 months
2

DFS in case of PALN metastases

to evaluate the prognostic impact, in terms of Disease Free Survival (DFS), of PALN metastases (for group A, only)

Time frame
48 months
3

OS in case of PALN metastases

to evaluate the prognostic impact, in terms of OS, of PALN metastases (for group A, only)

Time frame
48 months
4

predictive factors of PALN metastases

to evaluate possible pre- and intra-operative predictive factors of PALN metastases (for group A, only)

Time frame
12 months

Other outcomes

Sponsors and contacts

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