Multicenter Prospective Randomized Controlled Clinical Trial for Comparison Between Laparoscopic and Open Distal Pancreatectomy for Ductal Adenocarcinoma of the Pancreatic Body and Tail
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 244
- 试验地点
- 2
- 主要终点
- 2 year survival
研究概览
简要总结
When pancreatic cancer of the body and tail is diagnosed, a distal pancreatectomy is planned. This operation can be performed with open surgery, or with laparoscopic surgery. This study is a multicenter randomized controlled trial to evaluate the operative outcomes and survival of open versus laparoscopic distal pancreatectomy for pancreatic cancer of the body and tail.
详细描述
* Purpose
To compare the safety and oncologic feasibility of open versus laparoscopic distal pancreatectomy for the treatment of pancreatic ductal adenocarcinoma (PDAC) of the body and tail.
* Study method
Multicenter prospective randomized controlled trial Noninferiority analysis Patients diagnosed with PDAC of the body and tail, without evidence of distant metastasis or direct invasion of adjacent organs, will be randomly allocated to either the open distal pancreatectomy group or the laparoscopic distal pancreatectomy group. Postoperative outcomes and survival data will be analyzed.
* Number of subjects
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance score 0-2
- •Pancreatic ductal adenocarcinoma that is pathologically confirmed or shows characteristic radiologic features
- •Patients with resectable pancreatic cancer at the time of surgery (Including borderline resectable pancreatic cancer at the time of diagnosis or Locally advanced pancreatic cancer after chemotherapy or radiation therapy)
- •Lesion (within pancreatic body and tail) is located to the left of the left branch of the hepatic portal vein
- •No remote metastasis in preoperative imaging and not adjacent to the superior mesenteric vein, superior mesenteric artery, and abdominal artery
- •Patients without invasion of adjacent organs other than the left adrenal gland and mesocolon
- •Patients with informed consent
排除标准
- •Patients with remote metastasis at the time of diagnosis of pancreatic cancer
- •History of other malignancy (Inclusive if there is no evidence of recurrence after 5 years of treatment)
- •In the case of invasion of other organs other than the left adrenal gland and mesocolon
- •Where major vascular resection, such as the portal vein or abdominal artery, is required to secure negative resection
- •Recurrent pancreatic cancer
- •Patients with underlying diseases at high risk of general anesthesia
- •Preperitoneal or other organ metastases found during surgery
- •In case of previously undergone pancreatic resection
- •Other subject whom the investigator deems inappropriate
结局指标
主要结局
2 year survival
时间窗: 2 years
Overall survival at 2 years after surgery
次要结局
未报告次要终点
研究者
Ho-Seong Han
Professor
Seoul National University Hospital