NCT04600063招募中不适用
Randomized Controlled Phase II Study of Isolation Procedure Versus Conventional Procedure in Distal Pancreatosplenectomy for Pancreatic Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 11
- 主要终点
- 2-year recurrence-free survival
研究概览
简要总结
In the distal pancreatectomy (including pancreatic tail resection) for invasive ductal carcinoma of the pancreas, we evaluate the usefulness of a procedure of firstly transection of splenic arteries and veins (the isolation procedure group) compared to a conventional procedure of transection of the splenic vein at the end.
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
- 否
入选标准
- •Resectable pancreatic cancer (Adenocarcinoma, adenosquamous cell carcinoma, mucinous carcinoma, and anaplastic carcinoma according to the 7th edition of the regulations for handling pancreatic cancer)
- •ASA-PS (American Society of Anesthesiology, General condition classification) is Class 1-
- •Age are over 20 years old.
- •Able to understand the content of the research and has obtained written consent from the person himself/herself.
排除标准
- •Non-resectable pancreatic cancer by image diagnosis at the initial diagnosis
- •Cases suspected of portal vein (superior mesenteric vein) invasion
- •Patients with severe ischemic heart disease
- •Patients with cirrhosis or active hepatitis requiring treatment
- •Patients with dyspnea requiring oxygen administration
- •Patients undergoing dialysis due to chronic renal failure
- •Cases in which arterial reconstruction of the superior mesenteric artery, common hepatic artery, celiac artery, etc. is considered necessary
- •Patients with strong suspected paraaortic lymph node metastasis
- •Active double cancer thought to affect adverse events and prognosis
- •Long-term oral steroids that may affect adverse events
- •Patients who are considered to have difficulty participating in the study due to psychosis or psychiatric symptoms.
- •Cases other than invasive pancreatic ductal carcinoma by preoperative biopsy. Invasive intraductal papillary mucinous carcinoma (IPMC) is excluded.
- •Patients who cannot use both iodine drugs and gadnium drugs due to severe drug allergy
- •Cases where the prescribed procedure is difficult due to history of upper abdominal surgery such as stomach, spleen, kidney, liver, transverse colon, retroperitoneum including pancreas and pancreatitis
结局指标
主要结局
2-year recurrence-free survival
时间窗: Up to 24 months
Until 2 years after last entry case undergo surgery
次要结局
未报告次要终点
研究者
Hiroki Yamaue
Director, Principal Investigator, Professor of Second Department of Surgery
Wakayama Medical University
研究点 (11)
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