Efficacy and Safety of Endoscopic Submucosal Tunnel Dissection for Superficial Esophageal Squamous Cell Carcinoma: a Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- The procedure time
研究概览
简要总结
To evaluate the efficacy and safety profile of endoscopic submucosal tunnel dissection for superficial esophageal squamous cell carcinoma.
详细描述
This multicenter, prospective, randomized, controlled study aims to evaluate the efficacy and safety of the tunnel technique in ESD of superficial esophageal squamous cell carcinoma (ESCC). Specifically the tunnel technique would be compared to conventional method on the procedure time and the muscular layer injury rate in patients scheduled for ESD with indication of ESCC.
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
盲法说明
The operator only understands the operation method required by the patient and is unaware of the observation indicators
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years;
- •Biopsy confirmed early esophageal cancer and high-grade intraepithelial neoplasia (HGIN)which were eligible for conventional ESD indications;
- •Suspected localized mucosal lesions detected by endoscopy.
排除标准
- •Malignancy or other advanced disease with a life expectancy of < 6 months as judged by the investigator.
- •The ASA classification of physical status ≥ 4 as judged by the investigator.
- •Severe hepatic disease or renal disease
- •Ability to understand and the willingness to sign a written informed consent document.
- •Major cardiovascular event at enrollment or within 3 months prior to enrollment such as stroke, myocardial infarction, or hospitalization for treatment of unstable angina pectoris as judged by the investigator.
- •Haemorrhagic disorder.
- •Patients who had a history of esophagectomy or a recurrent lesion.
- •Planned treatment with: warfarin (including other vitamin K antagonists), cisapride,phenytoin, atazanavir, nelfinavir, digoxin, methotrexate, clopidogrel, tacrolimus,theophylline, lidocaine, nifedipine.
- •Pregnancy, planned pregnancy or lactation. Women of childbearing potential must use reliable and medically accepted methods of birth control, as judged by the investigator.
- •Known or suspected alcohol, drug or medication abuse.
- •Any condition associated with poor compliance as judged by the investigator.
- •Participation in any study involving administration of an investigational product or device within the preceding 14 days prior to enrollment.
- •Involvement in the planning and conduct of the study. Previous enrollment in the present study
结局指标
主要结局
The procedure time
时间窗: day 1
Procedure time was defined as the time from marking of the lesion until complete removal of the specimen,including hemostasis.
次要结局
- The rate of bleeding during operation(day 1)
- The rate of injury to the muscular layer(day 1)
研究者
Zhiguo Liu
Associate Professor
Xijing Hospital of Digestive Diseases