Dissecting the Pattern of Nodal Spread in Post-neoadjuvant Pancreatoduodenectomy

Study Overview
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Brief Summary
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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.

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

Conditions
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Pancreas Cancer, Pancreatic Adenocarcinoma

Intervention / Treatment
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* Procedure: Systematic lymphadenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-neoadjuvant pancreatoduodenectomy for localized pancreatic ductal adenocarcinoma. Exclusion Criteria: Oligometastatic disease Upfront pancreatectomy Incomplete lymphadenectomy Macroscopically incomplete resections Rare variants of pancreatic cancer
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metastatic involvement of second nodal echelon | Rate of metastases to nodes outside the main resection specimen (stations 6,8,12) | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metastatic involvement of single nodal stations | Rate of metastases in each station included in the lymphadenectomy protocol | 8 years | 
| Overall survival | Overall survival from pancreatectomy stratified by nodal echelon | 3 years | 
| Recurrence-free survival | Recurrence-free survival from pancreatectomy stratified by nodal echelon | 3 years | 
| Overall survival | Overall survival from pancreatectomy stratified by nodal stations | 8 years | 
| Recurrence-free survival | Recurrence-free survival from pancreatectomy stratified by nodal stations | 8 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatoduodenectomy, Lymphadenectomy, Lymph nodes, Pancreatic cancer