The Effect in Wedge Resection and IVb/V Resection of the Liver for Gallbladder Cancer Operation: Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Survival rates
研究概览
简要总结
The extent of hepatic resection for gallbladder cancer can be done from a wedge resection to 4b/5 bisegmentectomy. This study aims to compare the recurrence rates and survival rates between wedge resection group and bisegmentectomy group. Patients with T2 or T3 gallbladder cancer on preoperative CT exam or patients who were pathologically diagnosed as T2 or T3 gallbladder cancer after initial simple cholecystectomy were enrolled. All patients are randomly assigned to wedge resection or bisegmentectomy group. Number of patients in each group is 44. Primary endpoint is recurrence-free-survival rates and overall survival rates.
详细描述
The extent of hepatic resection for gallbladder cancer has a wide range. A partial hepatectomy involving the gallbladder fossa is a critical part of the resection but can range from a wedge resection to an anatomic resection of segments 4b and 5 to an extended right hepatectomy. This study enrolls Patients with T2 or T3 gallbladder cancer on preoperative CT exam or patients who were pathologically diagnosed as T2 or T3 gallbladder cancer after initial simple cholecystectomy. Eighty eight patients are randomized to wedge resection group or bisegmentectomy group. Except the extent of hepatic resection, all the procedures including hepatoduodenal,common hepatic, posterior pancreatic lymph node dissection are same.
Primary endpoint is recurrence-free-survival rates and overall survival rates.
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with T2 or T3 gallbladder cancer on preoperative CT exam
- •Patients who are pathologically diagnosed as T2 or T3 gallbladder cancer after initial simple cholecystectomy
排除标准
- •Peritoneal seeding or distant metastasis
- •Impossible to resect the cancer radically
- •Pathologically diagnosed to other malignancy such as adenosquamous carcinoma, sarcoma, etc.
- •R1 or R2 resection were pathologically diagnosed.
研究组 & 干预措施
wedge resection
The extent of hepatic resection is wedge resection of gallbladder fossa
干预措施: wedge resection (Procedure)
bisegmentectomy
The extent of hepatic resection is 4b/5 bisegmentectomy
干预措施: bisegmentectomy (Procedure)
结局指标
主要结局
Survival rates
时间窗: 1 year
3year 5 year
次要结局
未报告次要终点
研究者
YOU DONG DO
Associated Professor
Saint Vincent's Hospital, Korea