A Prospective Lymphadenectomy Protocol to Investigate the Pattern of Nodal Spread and Its Association With Oncologic Outcomes in Post-neoadjuvant Pancreatoduodenectomy
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
- 否
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
Giuseppe Malleo
Associate Professor of Surgery
Universita di Verona
