An observational study in Pancreas Cancer and Pancreatic Adenocarcinoma, sponsored by Universita di Verona. Recruiting at 1 site in Italy. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Universita di Verona · Observational
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 898 are open to participants now.
This study's planned enrollment of 850 is above the median of 200 across 620 observational studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Universita di Verona is the lead sponsor of 122 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive patients with localized pancreatic ductal adenocarcinoma receiving post-neoadjuvant pancreatoduodenectomy from June 2013were eligible for inclusion in the study.
Exclusion Criteria:
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.
Metastatic involvement of second nodal echelon
Rate of metastases to nodes outside the main resection specimen (stations 6,8,12)
Time frame: 3 years
Metastatic involvement of single nodal stations
Rate of metastases in each station included in the lymphadenectomy protocol
Time frame: 8 years
Overall survival
Overall survival from pancreatectomy stratified by nodal echelon
Time frame: 3 years
Recurrence-free survival
Recurrence-free survival from pancreatectomy stratified by nodal echelon
Time frame: 3 years
Overall survival
Overall survival from pancreatectomy stratified by nodal stations
Time frame: 8 years
Recurrence-free survival
Recurrence-free survival from pancreatectomy stratified by nodal stations
Time frame: 8 years
Plan to share: Undecided — Data will be available upon reasonable request.
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Universita di Verona