RATT Vs. VATT for Early-stage TETs

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Oct 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different surgical techniques for patients with early-stage thymic epithelial tumors, specifically comparing robotic-assisted thoracoscopic thymectomy (RATT) and video-assisted thoracoscopic thymectomy (VATT). The goal is to see which approach leads to better outcomes during and after surgery. Researchers will screen 100 patients at three medical centers in China to find those who qualify for participation.

To be eligible for this trial, patients must have a thymoma diagnosed through imaging tests like a CT or MRI, with a tumor size of 8 cm or smaller. They should also be in generally good health, able to understand the study, and willing to sign consent. However, patients with certain health issues, such as severe heart problems or other significant medical conditions, or those who have had previous surgeries on their chest, will not be included. Participants can expect to undergo one of the two surgical procedures and will be monitored for their recovery and overall results. The trial is still in the planning stages and has not started recruiting patients yet.

Gender

ALL

Eligibility criteria

• 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.