RecruitingNot ApplicableNCT06029621

Robot-assisted vs VATS for Thymoma

Comparison of Short-term and Longterm Outcomes Between Robot-assisted Thoracoscopy and Television-assisted Thoracoscopy Surgery Forthymoma : a Multicenter, Prospective, Randomized Controlled Study

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Enrollment

304 participants

Start Date

Nov 20, 2023

Study Type

INTERVENTIONAL

Conditions

Thymoma

Summary

The aim of this study is to explore the advantages of robot-assisted thymectomy in long-term survival benefits and short-term clinical efficacy compared with video-assisted thoracoscopic thymectomy based on a multi-center, prospective, randomized controlled clinical trial.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria9

) 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 Criteria12

) 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.