RATT Vs. VATT for Early-stage TETs (NCT06654830) | Clinical Trial Compass
Not Yet RecruitingPhase 2
RATT Vs. VATT for Early-stage TETs
100 participantsStarted 2024-11-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 o…