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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

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