A Prospective Randomized Controlled Study Comparing Standard and Extended Lymphadenectomy for Pancreatic Head Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 3 years overall survival rate
研究概览
简要总结
The aim of this study is to determine whether para-aortic lymph nodes(No.16) should be included in the lymphadenectomy during the pancreatoduodenectomy in order to improve the long-term survival of patients with pancreatic head ductal adenocarcinoma.
详细描述
Pancreatic cancer is now raised to the 7th leading cause of death. Surgical resection seems to be the unique curative therapy for pancreatic cancer. The pancreaticoduodenectomy is widely performed for the patients with pancreatic head cancer in recent decades. The lymphadenectomy is an indispensible procedure. In 2014, the International Study Group for Pancreatic Surgery (ISGPS) recommended a standard lymphadenectomy should include lymph node stations 5, 6, 8a, 12b1, 12b2, 12c, 13a, 13b, 14a, 14b, 17a, and 17b. However, no consensus was reached on Lymph node 16 in particular 16b1. There was no stronge evidence available concerning the impact on survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologic diagnosis of pancreatic ductal adenocarcinoma
- •Signed the informed consents
排除标准
- •Pathologic diagnosis of other pancreatic cancers
- •Pre-operative anti-cancer treatment
- •Recurrence patients
- •Patients with contraindication(hepatic/ respiratory/ renal dysfunction, etc )
- •Pre operative exam: Total bilirubin more than 250µmol/L
- •AJCC stage IV
- •Operation non radical
结局指标
主要结局
3 years overall survival rate
时间窗: 3 years post-operation
3 years overall survival rate
5 years overall survival rate
时间窗: 5 years post-operation
5 years overall survival rate
1 year overall survival rate
时间窗: 1 year post-operation
1 year overall survival rate
次要结局
- Postoperative Complications(Within 90 days or before discharge)
- 1, 3 & 5 years disease free survival rate(1, 3 & 5 years post-operation)
研究者
Weishen WANG
Principal Investigator
Ruijin Hospital