jRCT2032240323招募中不适用
Safety and performance confirmation study with dMD-003 - Study to evaluate the safety and performance of dMD-003 in patients scheduled to undergo planned two-stage hepatectomy -
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •(1) Patients with bilobar multiple liver metastasis from colon or rectal cancer who are eligible for a hepatectomy only if a planned two-stage hepatectomy is used.
- •(2) Patients scheduled to undergo a second-stage hepatectomy at 2 to 12 weeks after the date of the initial hepatectomy.
- •Other criteria.
排除标准
- •(1) Patients scheduled to undergo open resection along with the initial hepatectomy in the case of a concurrent primary colon or rectal tumor.
- •(2) Patients with a history of open surgery for a primary colon or rectal tumor.
- •(3) Patients who have previously undergone open surgery of the liver, bile duct, or upper abdomen.
- •Other criteria.
结局指标
主要结局
-
(1) Zuhlke classification (2) TORAD score
次要结局
未报告次要终点
研究者
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