Mohs Surgery Combind With Cryotherapy for Eyelid Malignant Tumors: a Prospective Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- recurrence rate of tumor
研究概览
简要总结
This study aim to investigate whether the prognosis of eyelid malignant tumor is better treated with Mohs surgery combind with cryotherapy than Mohs surgery only.
详细描述
This study is a randomized perspective study. American Joint Committee on Cancer was applied to define the cancer stage of patients recruited. Patients with Tis to T3cN0M0 will be randomized to receive Mohs surgery or Mohs suregery conbind cryotherapy. Patients will be followed for 3 years.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide written informed consent and comply with study assessments for the full duration of this study.
- •Definite pathology signs of eyelid basal cell carcinoma, squamous cell carcinoma and sebacous carcinoma, Stage Tis to T3CN0M0 based on American Joint Committee on Cancer.
- •Pathological examination showed the primary tumor was compeletely resected
排除标准
- •Any previous treatment in the study eye
- •Tumor complicated with infection
- •Any other tumors of the paticipants
- •Intolerate of surgery or anesthesia
研究组 & 干预措施
Mohs surgery conbind with cryotherapy
patients in this group received both Mohs surgery and cryotherapy.
干预措施: Mohs surgery (Procedure)
Mohs surgery conbind with cryotherapy
patients in this group received both Mohs surgery and cryotherapy.
干预措施: cryotherapy (Procedure)
Mohs surgery
patients in this group received only Mohs surgery.
干预措施: Mohs surgery (Procedure)
结局指标
主要结局
recurrence rate of tumor
时间窗: three years
measure the tumor recurrence rate for the two groups at three years
progression rate of tumor
时间窗: three years
measure the tumor progression rate for the two groups at three years
次要结局
- all cause mortailty(three years)
- side effects of Mohs surgery and cryotherapy in the treatment of eyelid malignant tumor(three years)
研究者
Huasheng Yang
Sun Yat-sen University
Sun Yat-sen University