Submandibular Gland Preservation During Neck Dissection for Oral Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 5-year survival rate
研究概览
简要总结
Trial design: a randomized controlled trial.
Eligibility criteria for participants: patients with primary early stage oral squamous cell carcinoma. Exclusion criteria: cancer of the floor of the mouth.
Interventions: submandibular gland is preserved during neck dissection for patients of the experimental group; submandibular gland is removed during neck dissection for patients of the control group.
Primary Parameters: survival rate, mortality rate
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary oral squamous cell carcinoma of early stage (T1N0 and T2N0).
排除标准
- •Cancer of the floor of the mouth.
结局指标
主要结局
5-year survival rate
时间窗: 5-year after operation
disease free survival rate
3-year survival rate
时间窗: 3-year after operation
disease free survival rate
1-year regional recurrence rate
时间窗: 1-year after operation
rate of participants with tumor recurrence in the neck
5-year regional recurrence rate
时间窗: 5-year after operation
rate of participants with tumor recurrence in the neck
3-year regional recurrence rate
时间窗: 3-year after operation
rate of participants with tumor recurrence in the neck
次要结局
未报告次要终点
研究者
Guang-Yan Yu
President of Chinese Stomatological Association
Peking University