Thymic Epithelial Tumor
Conditions
Keywords
thymic epithelial tumor, robot-assisted, video-assisted, thoracoscopic thymectomy
Brief summary
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.
Interventions
PROCEDURERATT
Robotic-assisted thoracoscopic thymectomy (RATT) will be performed using Da Vinci Robotic Surgical Systems.
PROCEDUREVATT
Video-assisted thoracoscopic thymectomy (VATT) was performed using traditional thoracoscopic systems.
Sponsors
Qilu Hospital of Shandong University
The First Affiliated Hospital of Zhengzhou University
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative draingage volume | Up to 7 days. | Postoperative draingage volume is the total draingage volume after surgery. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| complete recestion rate | 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 |
| serum interleukin-6 level at postoperaive day 1 | from the day of the surgery to the day of discharge. Up to 7 days |
Contacts
Primary ContactJianyong Ding, Ph.D.
Outcome results
None listed