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Trial Title:
Dissecting the Pattern of Nodal Spread in Post-neoadjuvant Pancreatoduodenectomy
NCT ID:
NCT06135649
Condition:
Pancreas Cancer
Pancreatic Adenocarcinoma
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
Pancreatoduodenectomy
Lymphadenectomy
Lymph nodes
Pancreatic cancer
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Systematic lymphadenectomy
Description:
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.
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.
Criteria for eligibility:
Study pop:
Consecutive patients with localized pancreatic ductal adenocarcinoma receiving
post-neoadjuvant pancreatoduodenectomy from June 2013were eligible for inclusion in the
study.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Unit of Pancreatic Surgery - G.B. Rossi Hospital, University of Verona Hospital Trust
Address:
City:
Verona
Zip:
37134
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giuseppe Malleo, MD PhD
Phone:
00390458126008
Email:
giuseppe.malleo@aovr.veneto.it
Start date:
January 2013
Completion date:
December 2024
Lead sponsor:
Agency:
Universita di Verona
Agency class:
Other
Source:
Universita di Verona
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06135649