跳至主要内容
临床试验/NCT06135649
NCT06135649招募中不适用

A Prospective Lymphadenectomy Protocol to Investigate the Pattern of Nodal Spread and Its Association With Oncologic Outcomes in Post-neoadjuvant Pancreatoduodenectomy

Universita di Verona1 个研究点 分布在 1 个国家目标入组 850 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
850
试验地点
1
主要终点
Metastatic involvement of second nodal echelon

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Post-neoadjuvant pancreatoduodenectomy for localized pancreatic ductal adenocarcinoma.

排除标准

  • Oligometastatic disease
  • Upfront pancreatectomy
  • Incomplete lymphadenectomy
  • Macroscopically incomplete resections
  • Rare variants of pancreatic cancer

结局指标

主要结局

Metastatic involvement of second nodal echelon

时间窗: 3 years

Rate of metastases to nodes outside the main resection specimen (stations 6,8,12)

次要结局

  • Overall survival(8 years)
  • Recurrence-free survival(8 years)
  • Metastatic involvement of single nodal stations(8 years)

研究者

发起方
Universita di Verona
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giuseppe Malleo

Associate Professor of Surgery

Universita di Verona

研究点 (1)

Loading locations...

相似试验