A Multi-center Clinical Study on the Feasibility and Safety of Radical Resection of Single-hole Inflatable Mediastinal Mirror Synchronization With Laparoscopic Esophageal Carcinoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 155
- 试验地点
- 21
- 主要终点
- Perioperative complication rate
研究概览
简要总结
This study is evaluating the feasibility and safety of radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma, as well as the clinical value of the radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma as a new minimally invasive operation for esophageal carcinoma.
详细描述
This is a prospective, multicenter, open clinical study in which 155 patients (including 5% shedding rate) who require surgical treatment are scheduled to be included in the study. Prior to any screening process, each subject / legal guardian should sign the informed consent form. Screening tests are used to determine whether each subject is eligible for the study. Eligible subjects who meet the standard will be treated with radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma and followed up until 3 years postoperatively. Primary study outcome are the prioperative complication rate and the number of intraoperative lymph node dissection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-85 years male and female
- •Patients with esophageal squamous cell carcinoma diagnosed by cytological or histological examination, requires surgical treatment
- •Patients in tumor stage of T1-2N0-1M0 confirmed by ultrasonic gastroscopy preoperatively;Or patients in T3N1M0 (IIIa) reached PR after neoadjuvant radio(chemo-) therapy, suitable for surgical resection
- •The tumor located in the chest or abdomen segment of esophagus
- •No surrounding vital organs were invaded and no distant metastasis
- •No obvious enlargement was shown in supraclavicular and retroperitoneal lymph nodes, no evidence of distant metastasis (M0)
- •Vital organs function normally: lung functions normally and could stand general anesthesia; NYHA heart function grade 0 ~ 1
- •Informed consent was signed as voluntarily before study, and patients and/or the legal representatives have the ability to fully understand test content/result, process and possible adverse reactions, and patients could comply with the requirements of the follow-up scheme
- •Reproductive women must show a negative pregnancy test, and it should be confirmed that both the women patient and her spouse are taking contraceptives recognized by researchers, and should keep taking this contraceptive by signing the informed consent until 3 months after the study was finished.
排除标准
- •Patients with other malignant tumors at the same time
- •Patients having surgery history of esophageal or gastric resection
- •Patients having a history of mediastinal surgery or vast peritoneal adhesion
- •Patients with heart thromboembolism at the same time
- •People with psychological, mental or nervous system diseases
- •Cachexia, severe malnutrition patients
- •Patients with history of recent recurrence of gastric ulcer, stomach bleeding and other severe basic diseases
- •Patients with blood coagulation dysfunction, HIV antibody positive, or surgical contraindications such as clinically poorly controlled serious infection
- •The subjects with other associated disease (such as liver and renal dysplasia, etc.) or drug combination, which could influence the study results recognized by the researchers
- •Patients participating in another clinical study
- •Patients with surgical instruments material allergy, or allergic constitution
- •The subjects are not judged by investigator to participate in this Clinical trial.
研究组 & 干预措施
Inflatable mediastinal mirror
Patients with especially esophageal squamous cell carcinoma ( ESCC ) who meet the inclusion criteria and do not meet the exclusion criteria will undergo radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma, and will be followed up until 3 years after discharging from the hospital.
干预措施: Single-hole inflatable mediastinal mirror (Procedure)
结局指标
主要结局
Perioperative complication rate
时间窗: Through operation completion, an average of 12 days
Perioperative complications include: pulmonary infection, respiratory failure, managed pleural effusion, heart failure, myocardial infarction, managed arrhythmia, anastomotic fistula or gastric fistula, recurrent laryngeal nerve injury, chylothorax, unscheduled reoperation
Number of lymph nodes dissected
时间窗: During the operation
number of lymph nodes dissected during operation
次要结局
- Intraoperative mortality(During the operation)
- Postoperative pain score(1-3 days after the operation)
- Postoperative icu monitoring time(0-12 days after the operation)
- Postoperative drainage tube indwelling time(0-12 days after the operation)
- Incidence of adverse events during and after operation(3 years)
- Postoperative hospital stay(Up to 2 weeks after the operation)
- Intraoperative bleeding volume(During the operation)
- Postoperative drainage(0-12 days after the operation)
- Operative time(During the operation)
- Proportion of patients undergoing thoracotomy or laparotomy(During the operation)
研究者
Qingdong Cao
Director of Thoracic and Cardiovascular Surgery Department
Fifth Affiliated Hospital, Sun Yat-Sen University