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

Comparison of Short-term and Longterm Outcomes Between Robot-assisted Thoracoscopy and Television-assisted Thoracoscopy Surgery Forthymoma : a Multicenter, Prospective, Randomized Controlled Study

This study is testing whether robot-assisted surgery or video-assisted surgery is better for treating patients with thymoma.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 304 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT06029621 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with clinically diagnosed thymic epithelial tumors who require thymectomy surgery.

Not a fit: Patients with advanced thymoma stages beyond IIIA or those who have received prior anti-thymoma therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and survival rates for patients with thymoma.

How similar studies have performed: While VATS has been widely adopted, the specific comparison of RATS to VATS for thymoma is relatively novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• 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

Conditions Thymoma