Robot-assisted vs VATS for Thymoma
Thymoma
About this trial
This is an interventional treatment trial for Thymoma
Eligibility Criteria
Inclusion Criteria: ) The age of the subjects on the day of signing the informed consent was ≥ 18 years old and < 75 years old, regardless of gender ; ) Chest thin-layer CT and MR showed anterior mediastinal space-occupying lesions, combined with relevant hematological indicators, the patient was clinically diagnosed as a thymic epithelial tumor with or without myasthenia gravis ( MG ) symptoms. ) need to accept thymectomy surgery ; ) Clinical stage I to IIIA ( AJCC-UICC TNM staging system ) ; ) The maximum diameter of the lesion < 5cm ; ) physical condition score 0 or 1 ( Eastern Cooperative Oncology Group ECOG scoring system ) ; ) Have not received any anti-thymoma therapy before, including but not limited to systemic chemotherapy, radiotherapy, etc. ; ) Preoperative major organ function meets the following criteria : Bone marrow function: hemoglobin ≥ 10.0 g / dL ( no blood transfusion within 28 days before hemoglobin examination ), absolute neutrophil count ≥ 1.5 × 109 / L, platelet count ≥ 100 × 109 / L ( no transfusion of apheresis platelets or IL-11 treatment within 14 days before platelet count examination ) ; coagulation function : INR and PT < 1.5 × ULN, APTT ≤ 1.5 × ULN ; liver function: transaminase ( ALT and AST ) ≤ 2.5 × ULN; total bilirubin ≤ 1.5 × ULN ( Gilbert's syndrome or liver metastasis subjects total bilirubin ≤ 2.5 × ULN ) ; renal function: serum creatinine clearance rate ≥ 60 mL/min ( calculated according to the Cockcroft-Gault formula ) ; ) voluntarily participated in and were able to undergo robot-assisted or thoracoscopic thymectomy, and complied with the study follow-up plan. Exclusion Criteria: ) Patients with myasthenia gravis crisis ; ) had undergone mediastinal surgery or cardiac surgery ; ) body mass index ( BMI ) ≥ 30 ; ) Patients with severe liver and kidney dysfunction ( ALT and/or AST more than three times the upper limit of normal, Cr more than the upper limit of normal ) ; ) combined with severe chronic lung diseases such as COPD, asthma, or interstitial lung disease ; ) suffering from uncontrolled heart, kidney, gastrointestinal, and infectious diseases and other complications ; ) patients with other malignant tumors or hematological diseases ; ) combined with chronic pain or preoperative use of opioid analgesics ; ) patients with thoracic deformity or combined with pectus carinatum and pectus excavatum ; ) have mental disorders, such as anxiety disorders ; ) pregnant and/or lactating women ; ) is currently participating in other interventional clinical studies.
Sites / Locations
- Shanghai Pulmonary Hospital
- The Second Affiliated Hospital Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
RATS for Thymectomy
VATS for Thymectomy
The operator of the surgical incision and the route of entry were determined, and the endoscope and surgical instruments were inserted through the operating hole. The phrenic nerve and diaphragm began to gradually separate upward while avoiding nerve damage. Subsequently, the innominate vein was dissected to observe the branches of the thymus vessels and clamped with a 5 mm Hem-o-Lok clamp. Continue to dissect the left side of the thymus until near the phrenic nerve. After the thymus was removed entirely, it was placed in a bag and removed through an incision. After the operation, a 28 Fr chest tube was placed through the incision to the chest top. An 18 G central venous catheter was placed at the level of the posterior axillary line to the posterior costophrenic angle, and about 10 cm was inserted.
The main operation principles and procedures of the operation are basically similar to those of the RATS and are completed under video-assisted thoracoscopic surgery.