Robot-assisted vs VATS for Thymoma

Recruiting now · Not applicable

Conditions studied: Thymoma

In brief

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.

Key facts

Study ID: NCT06029621
Run by: Shanghai Pulmonary Hospital, Shanghai, China
People needed: 304
Starts: 2023-11-20
Expected to finish: 2030-09-19
Last updated by the study team: 2024-02-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

) 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.

You may not qualify if…

) 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.

Where it is running

Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (enrolling)
The Second Affiliated Hospital Zhejiang University School of Medicine — Zhejiang, China

Full record on ClinicalTrials.gov

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