Comparing robot-assisted and video-assisted surgery for thymoma treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of robot-assisted thymectomy (RATS) versus video-assisted thoracoscopic surgery (VATS) in patients with thymoma. It is a multicenter, prospective, randomized controlled trial that will evaluate both short-term clinical outcomes and long-term survival benefits. Participants will undergo either RATS or VATS, and their results will be analyzed to determine which method offers better efficacy. The study focuses on patients diagnosed with thymic epithelial tumors and aims to provide insights into the oncological results of these surgical approaches.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai Pulmonary Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• The Second Affiliated Hospital Zhejiang University School of Medicine
  Zhejiang, China Not yet recruiting

Study contacts

• Principal investigator: Deping Zhao, MD,PhD — Shanghai Pulmonary Hospital, School of Medicine, Tongji University
• Study coordinator: Juemin Yu
• Email: yujm96@163.com
• Phone: +8615927548511

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tislelizumab plus anlotinib as a second-line treatment for thymoma and thymic carcinoma

  This trial will test whether combining tislelizumab with anlotinib is safe and can control thymoma or thymic carcinoma in people whose cancer progressed after first-line chemotherapy (with or without immunotherapy).

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT06838910

• Combining glucocorticoids with chemoradiotherapy for thymoma treatment

  This study is testing if adding a steroid called methylprednisolone to standard chemotherapy and radiation can help people with advanced or recurring thymoma have better treatment results.

  Recruiting Phase 2 Sun Yat-sen University · Guanzhou, Guangdong · NCT06730308

• Using hypofractionated radiotherapy for thymic epithelial tumors

  This study is testing if a shorter, more intense type of radiation therapy can help people with thymic epithelial tumors after surgery feel better and have fewer side effects compared to the standard treatment.

  Recruiting Xiangya Hospital of Central South University · Changsha, Hunan · NCT06692062

• Using AI to improve diagnosis and recurrence prediction in thymic tumors

  This study is testing if artificial intelligence can help doctors better diagnose thymic tumors and predict the chances of them coming back for patients with these rare cancers.

  Recruiting Erasmus Medical Center · Rotterdam, South Holland · NCT06301945

• Testing a new treatment for advanced thymic tumors

  This study is testing a new drug to see if it can help adults with advanced thymic tumors who haven't had success with other treatments.

  Recruiting at 4 sites Phase 2 Georgetown University · Palo Alto, California and 3 other locations · NCT06248515

• Adjuvant radiotherapy for thymoma after surgery

  This study is testing if adding radiation therapy after surgery can help people with stage II or III thymoma live longer and have better outcomes.

  Recruiting Fudan University · Shanghai, Shanghai Municipality · NCT02633553

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.