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Clinical Trials in China / NCT06029621
Recruiting Not applicable

Robot-assisted vs VATS for Thymoma

NCT06029621 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Phase
Not applicable
Started
2023-11-20
Last updated
2024-02-29

Condition(s) studied

Thymoma

Investigational drug(s) / intervention(s)

RATS for ThymectomyVATS for Thymectomy

RATS for Thymectomy: a minimally invasive surgical type for Thymoma: RATS

VATS for Thymectomy: a minimally invasive surgical type for Thymoma: VATS

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. ) The age of the subjects on the day of signing the informed consent was ≥ 18 years old and \< 75 years old, regardless of gender ; 2. ) 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. 3. ) need to accept thymectomy surgery ; 4. ) Clinical stage I to IIIA ( AJCC-UICC TNM staging system ) ; 5. ) The maximum diameter of the lesion \< 5cm ; 6. ) physical condition score 0 or 1 ( Eastern Cooperative Oncology Group ECOG scoring system ) ; 7. ) Have not received any anti-thymoma therapy before, including but not limited to systemic chemotherapy, radiotherapy, etc. ; 8. ) 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 ) ; 9. ) voluntarily participated in and were able to undergo robot-assisted or thoracoscopic thymectomy, and complied with the study follow-up plan. Exclusion Criteria: 1. ) Patients with myasthenia gravis crisis ; 2. ) had undergone mediastinal surgery or cardiac surgery ; 3. ) body mass index ( BMI ) ≥ 30 ; 4. ) 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 ) ; 5. ) combined with severe chronic lung diseases such as COPD, asthma, or interstitial lung disease ; 6. ) suffering from uncontrolled heart, kidney, gastrointestinal, and infectious diseases and other complications ; 7. ) patients with other malignant tumors or hematological diseases ; 8. ) combined with chronic pain or preoperative use of opioid analgesics ; 9. ) patients with thoracic deformity or combined with pectus carinatum and pectus excavatum ; 10. ) have mental disorders, such as anxiety disorders ; 11. ) pregnant and/or lactating women ; 12. ) is currently participating in other interventional clinical studies.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Shanghai Pulmonary Hospital Shanghai Shanghai Municipality Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine Zhejiang China Not Yet Recruiting

More Shanghai Pulmonary Hospital, Shanghai, China trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06029621 on ClinicalTrials.gov ↗ ← All trials in China