Para-aortic Lymphnodes Removal During Upfront Pancreaticoduodenectomy

NCT04571294 | Recruiting

• 1 other identifier: 451/20
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreas Cancer; Pancreaticoduodenal Lymphadenopathy; Pancreas Adenocarcinoma

Outcome Measures

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

  48 months

Secondary Outcomes (8)

• PALN metastases

  12 months

• DFS in case of PALN metastases

  48 months

• OS in case of PALN metastases

  48 months

• predictive factors of PALN metastases

  12 months

• overall post-operative morbidity

  12 months

Study Arms (2)

group A

EXPERIMENTAL

PALN removal

Procedure: removal of para-aortic lymphnodes (PALN)

group B

NO INTERVENTION

No PALN removal

Interventions

removal of para-aortic lymphnodes (PALN) PROCEDURE

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

group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Humanitas Hospital, Italy: lead

Study Sites (1)

Humanitas Research Hospital

Rozzano, Italy/Milan, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Gennaro Nappo, MD

CONTACT

00393471926757; gennaro.nappo@humanitas.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: October 1, 2020
• Study Start: May 26, 2020
• Primary Completion: December 31, 2024
• Study Completion: May 31, 2025
• Last Updated: October 4, 2024

Record last verified: 2024-10

Locations

IT (1)