| NCT ID | NCT06029621 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Pulmonary Hospital, Shanghai, China |
| Condition | Thymoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 304 participants |
| Start Date | 2023-11-20 |
| Primary Completion | 2030-09-19 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 304 participants in total. It began in 2023-11-20 with a primary completion date of 2030-09-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 based on a multi-center, prospective, randomized controlled clinical trial.
Eligibility Criteria
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.
Contact & Investigator
Deping Zhao, MD,PhD
PRINCIPAL INVESTIGATOR
Shanghai Pulmonary Hospital, School of Medicine, Tongji University
Frequently Asked Questions
Who can join the NCT06029621 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Thymoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06029621 currently recruiting?
Yes, NCT06029621 is actively recruiting participants. Contact the research team at yujm96@163.com for enrollment information.
Where is the NCT06029621 trial being conducted?
This trial is being conducted at Shanghai, China, Zhejiang, China.
Who is sponsoring the NCT06029621 clinical trial?
NCT06029621 is sponsored by Shanghai Pulmonary Hospital, Shanghai, China. The principal investigator is Deping Zhao, MD,PhD at Shanghai Pulmonary Hospital, School of Medicine, Tongji University. The trial plans to enroll 304 participants.