Prevalence and Consequences of Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer: a Prospective Population Based Multicenter Study. The PALN Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 7
- 主要终点
- Prevalence of paraaortic lymph nodes in pancreatic cancer in patients submitted to a tentative curative resection
研究概览
简要总结
Lymph node metastases are a strong prognostic predictor for pancreatic cancer. Para-aortic lymph nodes (PALN) are the final nodes for periampullary cancers before the cancer cells enter the systemic lymphatic circulation. Some consider these nodes to be regional lymph nodes and dissect them as a part of a routine lymphadenectomy for pancreatic cancer. Others argue that metastases to these nodes represent systemic disease and recommend that radical surgery including extended lymphadenectomy should be abandoned.
The aim of this study is to define the incidence and clinical consequences of PALN metastasis in patients submitted to a tentative curative resection for carcinoma of the head of the pancreas by systematically resecting paraaortic lymph nodes.
Primary outcome
- To determine incidence of PALN metastasis in patients submitted to a tentative curative resection
Secondary outcomes
- To determine prognosis of patients with PALN metastasis after a curative resection
- To determine incidence of metastasis in reginal lymph nodes in patients submitted to a tentative curative resection.
- To determine prognosis of patients with metastasis in regional lymph nodes in patients submitted to a tentative curative resection.
- To address the question of how to optimize the frozen section analyses of PALN as related to the final pathology report.
300 patients are planned to be included in the trial.
详细描述
Lymph node metastases are a strong prognostic predictor for pancreatic cancer. Para-aortic lymph nodes (PALN) (No. 16 nodes) are the final nodes for periampullary cancers before the cancer cells enter the systemic lymphatic circulation. Some consider these nodes to be regional lymph nodes and dissect them as a part of a routine lymphadenectomy for pancreatic cancer. Others argue that metastases to these nodes represent systemic disease and recommend that radical surgery including extended lymphadenectomy should be abandoned. There is no consensus whether to abort the resection if metastases in PALN are discovered pre- or perioperatively. Use of adjuvant and neoadjuvant chemotherapy may further affect the impact of lymph node metastases, including PALN.
The aim of this study is to define the incidence and clinical consequences of PALN metastasis in patients submitted to a tentative curative resection for carcinoma of the head of the pancreas by systematically resecting paraaortic lymph nodes.
Primary outcome
- To determine incidence of PALN metastasis in patients submitted to a tentative curative resection
Secondary outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Resectable suspected periampullary cancer (requiring duodenopancreatectomy) (NCCN guidelines 2020)
- •Borderline resectable periampullary cancer (requiring duodenopancreatectomy) (NCCN guidelines 2020)
- •Age >18 years
- •Written patient consent
排除标准
- •Contraindication for a radical resection procedure
- •Unresectable tumor (NCCN guidelines 2020) or metastatic disease (lgll station 16 not included)
- •Mental or organic disorders which could interfere with giving informed consent or receiving treatments
结局指标
主要结局
Prevalence of paraaortic lymph nodes in pancreatic cancer in patients submitted to a tentative curative resection
时间窗: 5 years
Frequency of metastases in paraaortic lymph nodes in patients with resectable pancreatic cancer will be assessed by systematically resecting these glands, irrespective of perioperative findings.
次要结局
- To determine prognosis of patients with metastasis in lgll station 8, 9 and 12 in patients submitted to a tentative curative resection.(6 years)
- To address the question of how to optimize the frozen section analyses (lgll station 16) as related to the final pathology report?(5 years)
- To determine prognosis of patients with PALN metastasis (lgll station 16) after a curative resection(6 years)
- To determine incidence of metastasis in lgll station 8, 9 and 12 in patients submitted to a tentative curative resection.(5 years)
研究者
Jon Unosson
Principal Investigator
Uppsala University Hospital