A Phase III, Randomized, Controlled Study of Endoscopic Submucosal Dissection Versus Photodynamic Therapy for Early Esophageal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 主要终点
- 2-year disease-free survival rate
研究概览
简要总结
The purpose of this study was to compare the efficacy and safety of Photodynamic therapy (PDT) and Endoscopic submucosal (ESD) dissection in the treatment of early esophageal cancer.
详细描述
Background: Photodynamic therapy (PDT) is recommended by the NCCN guidelines as an effective method for the treatment of early esophageal cancer. However, there is no clinical trial data so far on whether its efficacy can be compared with that of standard Endoscopic submucosal (ESD). Our team will conduct a detailed study on it.
Aim: to compare the efficacy and safety of Photodynamic therapy (PDT) and Endoscopic submucosal (ESD) dissection in the treatment of early esophageal cancer.
Methods: This study intends to recruit 46 patients with early esophageal cancer and randomly divide them into two groups: one group to receive ESD and the other group to receive PDT.The efficacy and safety were observed after 2 years of follow-up.
Primary endpoints: The recurrence rates at 3 months, 6 months, and 2 years were compared.
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
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High-grade intraepithelial neoplasia of the esophagus
- •18-80 years old
- •The tumor was confined to the lamina propria of the mucosa
- •The tumor invaded the submucosa and was limited to 200 microns
排除标准
- •The tumor invaded the entire circumference of the esophagus
- •The tumor invaded the muscularis or submucosa more than 200 microns
- •The patient has difficulty tolerating anesthesia due to other diseases
- •Pregnant or breastfeeding women
结局指标
主要结局
2-year disease-free survival rate
时间窗: 2 year
The percent of 2 year disease-free survival after random allocation, percent
次要结局
- Esophageal stenosis rate at 3 months(3 months)