Thymoma
Conditions
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.
Detailed description
Video-assisted thoracoscopic surgery ( VATS ) is widely used in thoracic surgery and has gradually replaced traditional thoracotomy in thymoma. As a new type of VATS, the long-term oncological results of robot-assisted thoracoscopic surgery in thymoma have not been verified. Therefore, we designed a multicenter, prospective, randomized controlled clinical trial to determine whether RATS thymectomy is as effective as VATS thymectomy in terms of short-term and long-term outcomes.
Interventions
PROCEDURERATS for Thymectomy
a minimally invasive surgical type for Thymoma: RATS
PROCEDUREVATS for Thymectomy
a minimally invasive surgical type for Thymoma: VATS
Sponsors
Shanghai Pulmonary Hospital, Shanghai, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
no masking
Intervention model description
RATS versus VATS
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-year overall survival (OS) | 5 year after surgery | OS at 5 year after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| quality of life (QOL) at 1 year by EORTC QLQ-C30 | at 1 year after surgery | Quality of life was assessed at 1 month, 6 months and 1 year after surgery. QQL was evaluated using the European Organization for the Treatment and Research of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) version 3.0 |
| quality of life (QOL) at 1 year by EQ-5D | at 1 year after surgery | Quality of life was assessed at 1 month, 6 months and 1 year after surgery. QQL was evaluated using the European Five Dimensional Health Scale (EQ-5D). |
| R0 rate | postoperative in-hospital stay up to 30 days | R0 radical rate |
| operative time | Intraoperative | the time of operation |
| blood loss | Intraoperative | blood loss in the operation |
| conversion rate | Intraoperative | the rate of conversion to open surgery in the operation |
| length of hospital stay (LOS) | postoperative in-hospital stay up to 30 days | length of stay in hospitalization |
| Pain score | at 1 year after surgery | Pain was assessed using a pain scale on the first day, 1 month, 6 months and 1 year after surgery. Pain was evaluated using the visual analogue scale (VAS) and the numerical rating scale (NRS), with higher scores indicating greater pain |
| Volume of drainage | postoperative in-hospital stay up to 30 days | Volume of drainage from the completion of catheter insertion to the removal of the thoracic tube |
| postoperative complications | postoperative in-hospital stay up to 30 days | mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula |
| 30-day mortality | postoperative in-hospital stay up to 30 days | 30-day mortality after surgery |
| 30-day readmission rate after surgery | postoperative in-hospital stay up to 30 days | Rate of readmission due to postoperative complications |
| 5-year disease-free survival (DFS) | 5 year after surgery | DFS at 5 year after surgery |
| Tumor recurrence rate | 5 year after surgery | The rate of recurrence of thymoma in patients after surgery |
| Catheterization days | postoperative in-hospital stay up to 30 days | The interval days from the completion of catheter insertion to the removal of the thoracic tube |
Countries
China
Contacts
Primary ContactJuemin Yu
Backup ContactDeping Zhao, MD,PhD
Outcome results
None listed