The Safety and Efficacy of Subxiphoid Minimally Invasive Resection of Giant Mediastinal Teratoma Assisted by Double Sternal Elevation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- The incidence of intraoperative and postoperative complications
研究概览
简要总结
For giant mediastinal teratomas, the only treatment option available is usually open-chest surgery, which causes significant trauma, leads to obvious postoperative pain and may result in long-term complications such as chest wall deformity. Currently, we have developed a new treatment method. We use a double retractor system to pull the upper and lower ends of the sternum, lifting it to obtain sufficient surgical space behind the sternum. This enables us to perform minimally invasive tumor resection through the subxiphoid approach with thoracoscopy. The advantages of this method include reduced surgical trauma and postoperative pain, shortened hospital stay, and improved cosmetic effect
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
- 10 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 10 - 70 years old, gender unrestricted; Preoperative enhanced CT or MRI confirms anterior mediastinal mass with the maximum diameter ≥ 7 cm; Intraoperative frozen section pathology confirms teratoma (mature or immature type); American Society of Anesthesiologists (ASA) classification grade I - III, with acceptable cardiopulmonary function for single-lung ventilation; No severe thoracic deformity or severe adhesion in the posterior mediastinum (assessed by preoperative imaging); Patients voluntarily sign the informed consent form, understanding the purpose and potential risks of the study.
排除标准
- •Tumors invading major blood vessels (such as the innominate vein, superior vena cava, or aorta) or the pericardium require combined vascular/pericardial resection and reconstruction; Tumors crossing the midline and encasing the trachea or esophagus require multidisciplinary joint surgery; Previous mediastinal surgery or radiotherapy history, leading to local anatomical structure disorder; Coagulation dysfunction (INR > 1.5 or platelet count < 50×10⁹/L); Severe immune deficiency (such as HIV infection, long-term glucocorticoid treatment); Pregnant or lactating women; Concurrent other malignant tumors (metastatic lesions need to be excluded); Severe cardiopulmonary diseases (such as COPD GOLD Ⅲ-Ⅳ grade, NYHA cardiac function Ⅲ-Ⅳ grade); Mental illness or cognitive impairment that cannot cooperate with postoperative follow-up; Participated in other clinical trials that may interfere with the results of this study.
结局指标
主要结局
The incidence of intraoperative and postoperative complications
时间窗: From the start of the surgery to 30 days after the operation
The incidence of intraoperative and postoperative complications
时间窗: From the start of the surgery to 30 days after the operation
次要结局
- Complete tumor resection rate(From the start of the surgery to two weeks after the operation)
- Postoperative function(From the start of the surgery to one month after the operation)
- Postoperative Quality of life(From the start of the surgery to six month after the operation)
- Complete tumor resection rate(From the start of the surgery to two weeks after the operation)
- Postoperative function(From the start of the surgery to one month after the operation)
- Postoperative Quality of life(From the start of the surgery to six month after the operation)
研究者
Jiang Fan
Chief surgeon
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine