Robot-assisted vs VATS for Thymoma

Launched by SHANGHAI PULMONARY HOSPITAL, SHANGHAI, CHINA · Sep 7, 2023

Keywords

ClinConnect Summary

This clinical trial is comparing two types of surgery for patients with a condition called thymoma, which is a tumor in the thymus gland located in the chest. The study aims to find out if robot-assisted thymectomy (using robotic technology) offers better long-term survival and quicker recovery compared to a traditional method called video-assisted thoracoscopic thymectomy (VATS). The trial is currently recruiting participants aged between 18 and 75 who have been diagnosed with thymoma and need surgery, as well as meet certain health criteria.

Participants in this trial can expect to be randomly assigned to receive either the robot-assisted surgery or the VATS method. They will undergo thorough health screenings to ensure they are suitable for the study and will need to follow up after the surgery. It's important to note that individuals with certain health issues, like severe lung or heart problems, or those who are pregnant, will not be eligible to participate. This trial is an opportunity to contribute to research that could improve surgery outcomes for future thymoma patients.

Gender

ALL

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.