About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Thymoma was diagnosed by chest enhanced CT or MRI (clinical stage: Masaoka Koga I-II) with AJCC/UICC TNM grade system (9th edition).
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
RATT
Procedure/SurgeryRobotic-assisted thoracoscopic thymectomy (RATT) will be performed using Da Vinci Robotic Surgical Systems.
VATT
Procedure/SurgeryVideo-assisted thoracoscopic thymectomy (VATT) was performed using traditional thoracoscopic systems.
Treatment groups
Trial outcomes
Primary outcomes
Postoperative draingage volume
Postoperative draingage volume is the total draingage volume after surgery.
Secondary outcomes
complete recestion rate
the counts of lymph node sampling
operative time
bleeding volume
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai Zhongshan Hospital
Lead sponsor
Qilu Hospital of Shandong University
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
This trial is not recruiting at the moment. You can still explore other options: