A Prospective Randomized Study of the Usefulness of the Artery First Approach in Pancreatic Cancer With Pancreaticoduodenectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 268
- 试验地点
- 2
- 主要终点
- 2 years recurrence free survival
研究概览
简要总结
This study is aimed to evaluate difference of the 2 year recurrence free survival after pancreaticoduodenectomy for pancreatic cancer between artery-first approach and conventional procedure groups.
详细描述
The patients will be divided into 2 groups
conventional group: The patients who included this group will undergo conventional pancreaticoduodenectomy (PD) or pylorus preserving pancreaticoduodenectomy (PPPD). We will identify and isolate superior mesenteric vein (SMV) before pancreatic resection. The surgeon will dissect tissue around superior mesenteric artery (SMA) and uncinate process of pancreas along the SMA.
Experimental group:
The patients who included this group will undergo PD or PPPD including total pancreatic mesopancreas excision and superior mesenteric artery approach. Before pancreatic transection, the surgeon will isolate superior mesenteric vein (SMV) and superior mesenteric artery (SMA). And the surgeon will dissect nerve plexus and lymph node around SMA. inferior pancreaticoduodenal artery (IPDA) and first jejunal artery will be identified and the surgeon will ligate according to surgical margin. Anastomosis will be performed as usual manners.
Postoperative manage is same in two groups. The investigators will compared 2 years recurrence free survival rate between conventional and experimental groups.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Resectable pancreatic head cancer
- •No systemic metastasis
- •Age > 20 years
- •The patients who understand informed consent and is able to agree with study
排除标准
- •The patients who have systemic metastasis
- •The patients who need neoadjuvant therapy in borderline resectable and locally advanced pancreatic cancer
- •Those with active or uncontrolled infections
- •Those with severe psychiatric / neurological disorders
- •Alcohol or other drug addicts
- •Patients with moderate or severe comorbidities who are thought to have an impact on quality of life or nutritional status (cirrhosis, chronic kidney failure, heart failure, etc.)
结局指标
主要结局
2 years recurrence free survival
时间窗: 2 years after surgery
locoregional or systemic tumor recurrence after surgery within 2 years
次要结局
- Recurrence pattern(2 years after surgery)
- R0 resection(7-10 days after surgery)
研究者
Song Cheol Kim
Professor
Asan Medical Center