NCT06135649

Dissecting the Pattern of Nodal Spread in Post-neoadjuvant Pancreatoduodenectomy

A Prospective Lymphadenectomy Protocol to Investigate the Pattern of Nodal Spread and Its Association With Oncologic Outcomes in Post-neoadjuvant Pancreatoduodenectomy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 850 (estimated)
• Sponsor: Universita di Verona · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

There has been long-standing debate about nodal dissection in pancreatoduodenectomy (PD) for pancreatic ductal adenocarcinoma (PDAC), with most studies examining the value of nodal yields, number of metastatic nodes and spatial location of metastases being conducted in the upfront surgery setting. With increasing use of a chemotherapy-first approach even in early stage PDAC, the validity of nodal parameters in post-treatment PD has been brought into question due to therapy-induced lymph node (LN) shrinkage. However, the available information is based on retrospective data or administrative registries, which only considered the number of examined and metastatic nodes, without detailed information regarding the dissection protocol and the influence of nodal metastases location. Back in 2013, corresponding to the standard lymphadenectomy definition release by the International Study Group of Pancreatic Surgery (ISGPS) and the diffusion of multi-agent chemotherapy regimens, an institutional, station-based nodal dissection protocol was established for post-neoadjuvant PD. The aim was to investigate whether the pattern of metastatic spread within the nodal basin is a superior quality metric for prognosis relative to the count-based classification system.

Conditions

• Pancreas Cancer
• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
PROCEDURE	Systematic lymphadenectomy	The nodal dissection protocol included the ISGPS lymphadenectomy stations (5, 6, 8a, 12b-c, 13, 14a-b, and 17) extended to stations contiguous to the regional basin (8p, 12a-p, and jejunal mesentery nodes). Stations embedded in the PD specimen (13, 14a-b, 17 and jejunal mesentery LN) were defined as first nodal echelon, while stations sampled as distinct specimens (5, 6, 8a-p, 12a-b-p-c) were defined as second nodal echelon.

Timeline

• Start date: 2013-01-01
• Primary completion: 2019-12-01
• Completion: 2024-12-01
• First posted: 2023-11-18
• Last updated: 2023-11-18

Locations

1 site across 1 country: Italy