Multicenter, Prospective, Randomized and Controlled Clinical Study 0f CO2 Laser and Open Surgery for T1N0 Glottic Squamous Cell Carcinoma With Anterior Commissure Involved
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 402
- 试验地点
- 1
- 主要终点
- disease-free survival
研究概览
简要总结
Open surgery and CO2 laser surgery are both established treatment modalities for T1N0 glottic carcinoma. It is controversial for T1N0 glottic carcinoma with anterior commissure involved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T1N0 SCC of glottic carcinoma with anterior commissure involve
- •No nodal metastasis and distant metastasis
- •All patients must have CT/MR and electronic laryngoscope test before surgery and after surgery
- •Expected lifetime>1 year
- •Patients and families agreed to participate in the test and sign the informed consent
- •Without cognitive impairment.
排除标准
- •With severe cardiac insufficiency Liver and kidney function is not complete systemic infection patients
- •Patients with pregnancy and lactation
- •Have surgery contraindications
研究组 & 干预措施
CO2 laser surgery
CO2 Laser surgery for T1N0 Glottic Squamous Cell Carcinoma With Anterior Commissure Involved. All patients, under general anesthesia, underwent endoscopic excision of the lesion using a carbon dioxide (CO2) laser (Sharplan 100) coupled with a microscope (Zeiss) set to an output power of between 5 and 12 W in superpulse mode. The lesion's resection was accomplished in a radical fashion, with a free margin of 2 mm. For lesions which involved the anterior commissure, the excision plane always uncovered the cartilage.
干预措施: CO2 Laser surgery (Procedure)
Open surgery
Open Surgery for T1N0 Glottic Squamous Cell Carcinoma With Anterior Commissure Involved.
open surgery :Frontolateral Vertical Partial Laryngectomy or laryngofissure with cordectomy was accomplished in a radical fashion, with a free margin of 2 mm.
干预措施: Open Surgery (Procedure)
结局指标
主要结局
disease-free survival
时间窗: 5 years
次要结局
- recurrence rate(5 years)
研究者
Xuekui Liu
chief physician
Sun Yat-sen University