Robot-assisted vs VATS for Thymoma

Status:

RECRUITING

Robot-assisted vs VATS for Thymoma

Lead Sponsor:

Shanghai Pulmonary Hospital, Shanghai, China

Conditions:

Thymoma

Eligibility:

All Genders

18-75 years

Phase:

Brief 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 ba...

Detailed Description

Video-assisted thoracoscopic surgery ( VATS ) is widely used in thoracic surgery and has gradually replaced traditional thoracotomy in thymoma. As a new type of VATS, the long-term oncological results...

Eligibility Criteria

Inclusion

) 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

) 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.

Key Trial Info

Start Date :

November 20 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 19 2030

Estimated Enrollment :

304 Patients enrolled

Trial Details

Trial ID

NCT06029621

Start Date

November 20 2023

End Date

September 19 2030

Last Update

February 29 2024

Active Locations (2)

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Page 1 of 1 (2 locations)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Zhejiang, China

Trial Details

Trial ID

NCT06029621

Start Date

November 20 2023

End Date

September 19 2030

Last Update

February 29 2024

Status: