Dissecting the Pattern of Nodal Spread in Post-neoadjuvant Pancreatoduodenectomy

Recruiting

• Conditions: Pancreas Cancer; Pancreatic Adenocarcinoma

• Registration Number: NCT06135649
• Lead Sponsor: Universita di Verona

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

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2019-12
• Status Verified: 2023-11
• Study First Submitted: 2023-11-12
• Study First Submitted QC: 2023-11-15
• Last Update Submitted: 2023-11-15
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 850

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Metastatic involvement of second nodal echelon	3 years	Rate of metastases to nodes outside the main resection specimen (stations 6,8,12)

Secondary Outcome Measures

Name	Time	Method
Recurrence-free survival	8 years	Recurrence-free survival from pancreatectomy stratified by nodal stations
Metastatic involvement of single nodal stations	8 years	Rate of metastases in each station included in the lymphadenectomy protocol
Overall survival	8 years	Overall survival from pancreatectomy stratified by nodal stations

Trial Locations

Locations (1)

Unit of Pancreatic Surgery - G.B. Rossi Hospital, University of Verona Hospital Trust; 🇮🇹 Verona, VR, Italy