Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06135649
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-11-12
Brief Title:
Dissecting the Pattern of Nodal Spread in Post-neoadjuvant Pancreatoduodenectomy
Sponsor:
Universita di Verona
Organization:
Universita di Verona
Study Overview
Official Title:
A Prospective Lymphadenectomy Protocol to Investigate the Pattern of Nodal Spread and Its Association With Oncologic Outcomes in Post-neoadjuvant Pancreatoduodenectomy
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None