NCT06654830尚未招募2 期
Robotic-assisted Versus Video-assisted Thoracoscopic Thymectomy for Thymic Epithelial Tumor in Stage I-II: a Prospective, Multi-center, Randomized Controlled Trial
Shanghai Zhongshan Hospital0 个研究点目标入组 100 人开始时间: 2024年11月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Postoperative draingage volume
研究概览
简要总结
This study is a prospective, multicenter, phase II randomized controlled trial. We plan to screen 100 eligible thymoma patients for robotic-assisted thoracoscopic thymectomy (RATT) or video-assisted thoracoscopic thymectomy (VATT) at three medical centers in China. The trial was aimed to compare the perioperative outcomes between the two approaches.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thymoma was diagnosed by chest enhanced CT or MRI (clinical stage: Masaoka Koga I-II) with AJCC/UICC TNM grade system (9th edition).
- •The patients whose tumor diameter was not larger than 8 cm; The patients with the estimated survival time should be over 12 months; ASA grade：1-2; The patients should have no functional disorders in main organs; The patients should be able to understand our research and sign the informed consent.
排除标准
- •Imaging examination showed that the tumor had invasion of surrounding organs, pleural or pericardial dissemination, lymphatic or hematogenous metastasis; Patients with myasthenia gravis; Patients had undergone a sternotomy; The patients have proved history of congestive heart failure, angina without good control with medicine; ECG-proved penetrating myocardial infarction; hypertension with bad control; valvulopathy with clinical significance; arrhythmia with high risk and out of control; The patients have severe systematic intercurrent disease, such as active infection or poorly controlled diabetes; coagulation disorders; hemorrhagic tendency or under treatment of thrombolysis or anticoagulant therapy; Female who is positive for serum pregnancy test or during lactation period; The patients have history of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation; The patients have history of peripheral nerve system disorders, obvious mental disorders or central nerve system disorders; The patients attend other clinical trials.
结局指标
主要结局
Postoperative draingage volume
时间窗: Up to 7 days.
Postoperative draingage volume is the total draingage volume after surgery.
次要结局
- complete recestion rate(Up to 7 days.)
- the counts of lymph node sampling(From the time at start of the surgery to the time at end of the surgery. Up to 7 days.)
- operative time(From the time at start of the surgery to the time at end of the surgery. Up to 7 days.)
- bleeding volume(From the time at start of the surgery to the time at end of the surgery. Up to 7 days.)
- duration of drainage(from the day of the surgery to the day of removal of drainage tubes. Up to 7 days.)
- postoperative hospital stays(from the day of the surgery to the day of discharge. Up to 30 days)
- re-operation rate(from the day of the surgery to the day of discharge. Up to 7 days)
- C-reactive protein level at postoperaive day 1(from the day of the surgery to the day of discharge. Up to 7 days)
- C-reactive protein level at postoperaive day 2(from the day of the surgery to the day of discharge. Up to 7 days)
- serum interleukin-6 level at postoperaive day 1(from the day of the surgery to the day of discharge. Up to 7 days)
- serum interleukin-6 level at postoperaive day 2(from the day of the surgery to the day of discharge. Up to 7 days)
- serum procalcitonin level at postoperaive day 1(from the day of the surgery to the day of discharge. Up to 7 days)
- serum procalcitonin level at postoperaive day 2(from the day of the surgery to the day of discharge. Up to 7 days)
- pain visual analogue scale score at postoperative day 1, 2, 3 and 7(from the day of the surgery to the postoperative day 7. Up to 7 days)
- quality of life score at postoperative day 30, 60 and 180(from the day of the surgery to the postoperative day 180. Up to 180 days)
- complication rate(from the day of the surgery to the day of discharge. Up to 30 days)
- 3-year disease-free survival(from the day of the surgery to the postoperative 3 years. Up to 3 years)
- 3-year overall survival(from the day of the surgery to the postoperative 3 years. Up to 3 years)
研究者
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